Excel knee Clinical Studies

REPORT OF CLINICAL EVALUATION OF MORE THAN 5 YEARS OF EVOLUTION OF THE EXCEL TOTAL KNEE PROSTHESIS (TKN)

Addressed to: TRAIBER S.L.

MARCH 2011

SIGNATURES AND CONDITIONS SHEET

Date: March 2nd, 2011

Report prepared by: Mr./Mrs. Joaquín López López

Signature:

Reviewed by:

Mr./Mrs. Carlos Atienza Vicente Mr./Mrs. José Luis Peris Serra Area Director Line Director Signature: Signature: Approved by Mr./Mrs. Jaime M. Prat Pastor I+D Director Signature: CONDITIONS 1. The IBV (Biomechanic Institute of Valencia) only responds of the consigned results in the report and exclusively referred to the materials or samples indicated in it, and remaining in its own. Except for an express mention, the samples have been chosen freely and sent by the solicitor. 2. IBV is not responsible of the wrong interpretation or use of this report, whose total or partial reproduction for advertising, without expressed authorization granted by IBV, is forbidden. 3. The results are considered as the solicitor's property, and without previous authorization, IBV will abstain from communicating it to a mediator. 4. This report's sample of essay-object will remain at IBV during a period of time of six months since its emission date. After this deadline, it will be proceed to destroy, for which any complaint must be made during that period of time.

CONTENT SIGNATURE AND CONDITIONS SHEET 0. PROBLEM APPROACHING AND OBJECTIVES 1. CLINICAL EVALUATION REPORT 1.1. GENERAL DETAILS 1.2. DESCRIPTION OF THE PROSTHESIS AND FURTHER APPLICATION 1.3. USE INDICATIONS AND PRECAUTIONS 1.4. EVALUATION CONTEXT AND CHOOSING OF THE KIND OF CLINICAL DATA 1.5. SUMMARY OF CLINICAL DATA AND EVALUATION 1.6. DATA ANALYSIS 1.7. CONCLUSIONS ANNEX I

0. PROBLEM APPROACHING AND OBJECTIVES Traiber needs to justify before the Spanish Medicine Agency (Agencia Española del Medicamento) the functional validity of the Excel total knee prosthesis, due to the change of medical device class, from IIb to III. The aim of the project is to justify the clinical proficiency of the total knee prosthesis made and developed by Traiber through the elaboration of a clinical monitoring report of more than 5 years of evolution of the aforementioned prosthesis, adapting the clinical information and documentation that Traiber has made available to IBV, to the European directions for the medical device "MEDDEV.2.7.1 Rev.3 (2009)".

1. CLINICAL EVALUATION REPORT 1.1. GENERAL DETAILS

Manufacturer:

TRAIBER S.L.

C/ JUAN OLIVER Nº 13-15-17.

POLÍGONO AGRO-REUS

43206 REUS (TARRAGONA)

Product:

KNEE PROSTHESIS

Model: EXCEL

1.2. DESCRIPTION OF THE PROSTHESIS The Excel total knee prosthesis is a class III medical device whose aim is to substitute the original knee articulation in order to restore its own functions. Mainly, the loading transmission in the lower member and its mobility, allowing the patient to develop a normal physical activity with relief or pain absence. This prosthesis is formed by a system of components that interact among them, and can be adjusted in two versions, cemented and non-cemented, according to the clinical need and the surgeon's criteria at the moment of intervention. The components of the prosthesis are detailed below (see Figure 1):

• Patella: Component made in Ultra high molecular weight polyethylene (UHMWPE according to ISO 5834-1, ISO 5834-2 and ASTM F648) of white color. It replaces the articulation part of the natural patella (kneecap), in where the use of bone cement, and articulates with the trochlea in the femoral component. There is a wide range of sizes available, that can be used with any version and size of the femoral components, in the following diameters: 25, 30 and 35 mm.

• Cemented anatomical condyle: Component made in CrCo alloy according to the norm ISO 5832-4, of shiny metallic color. A family of 4 sizes (from 0 to 3) is available, as well as a right and left component per size.

• Non-cemented anatomical condyle: Component made in CrCo plus hydroxyapatite alloy, of shiny metallic and hydroxyapatite white colors. A family of 4 sizes (from 0 to 3) is available, as well as a right and left component per size.

• Posterior-stabilized anatomical condyle: Component made in CrCo alloy, of shiny metallic color. A family of 4 sizes (from 0 to 3) is available, as well as a right and left component per size.

• Cemented tibial baseplate: Component made in titanium alloy Ti6Al4V, according to ISO 5832-1, ISO 5832-3 and ASTM F136, of titanium metallic color. A family of 5 sizes (from 0 to 4) is available, as well as a right and left component per size.

• Non-cemented tibial baseplate: Component made in titanium alloy Ti6Al4V plus hydroxyapatite, of titanium metallic and hydroxyapatite white colors. A family of 5 sizes (from 0 to 4) is available, as well as a right and left component per size.

• Tibial screw: All the screws used to fix the elements of the total knee system are made in titanium alloy Ti6Al4V, , of titanium metallic color, with diameters of 6,5 mm and lengths from 30 to 50 mm.

• Normal polyethylene tibial insert: Component made in Ultra high molecular weight polyethylene, of white color. A family of 4 sizes (from 0 to 3) and from 6 to 15 mm of thickness per size is available.

• Posterior-stabilized polyethylene tibial insert: Component made in Ultra high molecular weight polyethylene, of white color. A family of 4 sizes (from 0 to 3) and from 6 to 15 mm of thickness per size is available.

Figure 1. Image of the EXCEL total knee prosthesis, in where its main components are detailed The chemical composition, as well as the mechanical properties of these materials are in compliance with the current normative, as observed in the manufacturer's technical documents.

1.3. USE INDICATIONS AND PRECAUTIONS Indications The knee prosthesis is indicated for those clinical cases requiring the replacement of the knee articulation or arthroplasty. Due to the higher magnitude of the intra-articulation forces it is subject to and the great mobility it should have, the knee articulation is very prone to suffer degenerative pathologies, such as arthritis or arthrosis. The main reason to substitute a knee by prosthesis is pain, associated to a severe degradation of the articulation, that usually is accompanied of a disability or severe functional loss. That is why the main goal of a knee prosthesis is, firstly, to avoid the pain, and secondly, to recover the articulation mobility. Although both goals are accomplished, the function of the knee can be recovered and carry out a normal life without needing supporting or other kinds of technical helps. The knee arthroplasty is prescribed only when symptoms and disability are severe. Alternative techniques, such as tibial osteotomy, will be preferable if viable. The indications of a knee articulation substitution are:

• Gonarthrosis (considering factors such as age, activity level or weight). • The arthroplasty must be avoided in overweighed 60 years old or younger patients, although the

final decision is made by the patient and the surgeon together. • Severe or rheumatoid inflammatory arthritis. • Post-traumatic arthrosis (except for young patients). • Because of the failure of a tibial osteotomy that did not accomplished its goal of curing the

symptoms, or when they appear after a certain period of time as the consequence of a progressive arthrosis.

CrCo anatomic condyle

PE Patella

PE Insert

Ti6AlV tibial baseplate

Counter-indications

• Presence of an active infection in any region. • Stable painless arthrodesis in good position. • The weak genu recurvatum and muscular paralysis are more prone to re-appear after the

articulation replacement. • Weakness of the quadriceps. • Process of fast destruction of the bone mass (progressive generalized osteopenia, localized

osteoporosis, etc.), at least while the process progression is not controlled. • The knee arthroplasty is not recommended in case of: other diseases (heart, lung, metabolism,

etc.), patients who cannot walk after the arthroplasty due to other problems, patients with skeletal immaturity.

• Obesity, because can produce loadings in the prosthesis that would make the implant fail. • Allergy to any material compounding the prosthesis components.

Pre-operative precautions

• The possibilities of success of the knee arthroplasty rise with a good pre-operative planning, selecting the implant's size, shape and design appropiately.

• Consult the stock before intervention. Helped by the product catalogue, check the stock of all the sizes or measures of the components needed to complete de prosthesis, since a wrong choosing often makes the prosthesis fail.

• The patients must go on a allergy test to avoid possible intolerance reactions to the materials to be implanted.

• Be sure that the operating room meets good asepsis conditions. • Since this is a sterile product, reject that product whose package is faulty, incomplete or open.

Check date of expiration.

Precautions during the operation

• The surgery associated to this product must be made by expert doctors in these kinds of interventions.

• The manipulation of this product in the operating room must be meticulous, avoiding thus the contact to abrasive substances or other metallic ones.

• Dimensions, morphology and the superficial finish of this prosthesis cannot be modified. • The trial prosthesis instruments and components specially designed by TRAIBER must be used.

Consult the product catalogue.

• The different components that TRAIBER manufactures for knee arthroplasties have been conceived to ensure its exchangeability. Therefore, TRAIBER is not responsible of the possible implant combination of different brand or manufacturer.

• Before using this product, check if the marked data and the label coincide. • Try to reduce the time passed between the product opening and implantation.

For cemented implants, follow attentively the cement's making instructions. Post-operative precautions

• The doctor must establish a evaluation monitoring to the patient through periodic check-outs and determine the guidelines to be followed. Also, the doctor will tell the patient that the duration of this product is determined by his/her weight and activity level.

• It must be considered that an articulation replacement cannot support the same loadings and activity levels than the healthy bone. All the prosthesis for articulation replacement require a careful settling and an adequate bone support, and must be limited to functional loadings.

• If image analysis techniques are used, be sure that the implant is compatible to the selected technique.

• This product is susceptible to be detected by metal detection devices. • The surgeon must advice weight loss for the obese people, in order to improve the functional

capability and the long-term result of the arthroplasty.

Side effects

• Deformation or breaking of the implant for wearing out or fatigue. • Local infection - this is the main potential complication. • Loosening and/or migration of the implant with loss of the initial correction, producing pains to the

patient. It must be caused by a mechanical overload, osteoporosis, or a well specified or well unspecified immunological reaction to strange bodies.

• Wearing out: Loss of mechanical resistance and functionality. Particle liberation: Immunological reaction.

• If the prosthesis does not fulfills its foreseen mobility: Stiffness caused by intra-articulation adherences. Instability causing patellar or femorotibial dislocation.

• Failure by dislocation due to an unexpected mobility cause by improper or excessive efforts.

Occasionally, an additional surgical intervention can be needed due to the incapability to return to a normal activity in a daily basis, either correcting some of these adverse reactions or replacing the worn out prosthesis. The doctor will define end of the prosthesis' lifespan - when it doesn't successfully fulfills the function it was implanted for any longer. nevertheless, if the implant breaks or loose during its lifespan, the implied components must be extracted to prevent injuries caused by the presence of sharp edges or component migration. If this happens, a new knee prosthesis must be implanted.

STERILIZATION

• All the components of this product are sterilized before being provided. • Since the sterility of the product is guaranteed for a limited time, the date of expiration must be

checked. • These provided sterile products cannot be sterilized again. TRAIBER is not responsible of re-

sterilizations made in the hospital. • Whether this implant is replaced by another and is thrown away afterwards, the sterilization of the

extracted implant is recommended, using a valid method in the hospital, due to its infectious potential.

PRESERVING AND STORING Preserve this product in a place with good hygienic conditions, without humidity, protected against direct light beams and very extreme temperature. The package materials, either primary and secondary, are the 1-mm-thick co-polyester EASTAR PETG 6763 with Tyvek paper. For the external package, the folding stucco pasteboard with retractable plastic. The primary and secondary packages are in shape of thermo-formed blister, with hermetic thermo-sealed clasp, everything in a clean room. The external package is a box with a safety clasp protected by a retractable plastic film. All of the product have been packed according to the requirements established in the norms ISO 6018, ISO 11607, ISO 8828 and UNE-EN 868-1.

1.4. EVALUATION CONTEXT AND CHOOSING OF THE KIND OF CLINICAL DATA

The Traiber Excel knee prosthesis is sold since 1995 and based in a highly consolidated technology for this kind of prosthesis. In order to have a monitoring after selling, a process of recompilation of data generated through the multi-center clinical use of the presented prosthesis. The monitoring protocols were made in:

• "La Princesa" University Hospital, Madrid • "San Juan" University Hospital, Reus

The design of the protocol (attached to Annex I) was made by Antonio Ruiz Guillen, M.D., and the data treatment was made by the Orthopedic Surgery Service of San Juan Hospital, whose service chief is Dr. Ruiz. Reviews will be made on a regular basis, if no problems are presented, one month, six months, one year, three years, and five years after the surgery. For the present monitoring study, files having last previous reviews have been picked. The ones that were not made, for any reason (death, displacement, etc) were not included within the protocol, since the file was incomplete. After this, TRAIBER has four monitoring reports available, of more than five years of evolution of the Excel total knee prosthesis (TKN), from the years 2003, 2004, 2005 and 2006 (attached in the Annex I).

1.5 CLINICAL DATA AND EVALUATION SUMMARY A summary chart is presented below with the most relevant data of the monitoring reports (Appendix I). Every report belongs to a retrospective study, where more than 100 knees prosthesis have been checked in a minimum period of 5 years of evolution, the evaluation of that evolution has been done from the radiological and clinical point of view.

Chart 1. Summary of the relevant data of the arthoplasties with the TKP Excel.

Year of the report

Patients Knees Monitoring Gender Diagnosis Result measure

Notes

2003 99 99 > 5 years 76.77% women

93.94% gonarthrosis

VAS (visual analog pain scale)

2004 104 104 > 5 years 77.88% women

95.19% gonarthrosis

Survival is not considered

2005 119 119 > 5 years 76.47% women

94.12% gonarthrosis

Knee score A retrospective study has been done

2006 128 128 > 5 years 82.03% women

92,97% gonarthrosis

Functional knee score

The purpose of doing a data evaluation is to understand the achievements and limitations of the clinical data. In this respect, is necessarily evaluate the provided data in the monitoring reports, with the intention of determine the adaptation of these (relevance for the prosthesis) and its contribution to show the prosthesis’ safety and functionality. In order to do the evaluation of the data, certain criteria have been established and being used in a consistent way. In Chart 2 the criteria for the evaluation of the provided data adaptation are shown. To evaluate the data contribution, taking in account the kind of study (“case series”: the prosthesis has been used in a group of patients and the results have been presented in reports, without a control group for comparison), the aspects that are more relevant for the impact in the results interpretation have been considered (Chart 3). In Charts 2 and 3, the grade of importance is used to the evaluation of the contribution data solidity to demonstrate the functionality and the safety of the knee prosthesis set. So that as much criteria are graded as type 1, the greater the value of the evidence given by the monitoring reports data. However, is not expected that the relative importance of each category were counted in a global punctuation. Chart 2. Criteria for the evaluation of the data adaptation

Adaptation criteria Description Qualification system Appropriate product Were the data provided by the

prosthesis? D1 Real prosthesis D2 Equivalent prosthesis D3 Other prosthesis

Appropriate application of the prosthesis

Was the prosthesis used with the same purpose use than expected?

A1 Same use A2 Slight deviation A3 Large deviation

Group of suitable patients Were the data provided from a group of patients representative of the population, in which the treatment is intended (age, sex, etc.) and clinical condition (pathology, state, severity, etc.)?

P1 Applicable P2 Limited P3 Different population

Reports/acceptable compilation of data

Do the reports have enough information to be able to conduct a rational and objective assessment?

R1 High quality R2 Minor deficiency R3 Insufficient information

Chart 3. Criteria for the evaluation of the data contribution to the functionality and safety.

Contribution criteria Description Grade system Source of data Was the design of the study appropriate? T1 Yes

T2 No Results measurement Do the report's results show the

intended functionality of the prosthesis, and were assessed using objective criteria?

O1 Yes O2 No

Monitoring Is the duration of the monitoring enough to assess the effects of the treatment and identify the associated difficulties?

F1 Yes F2 No

Statistical significance Has a statistical analysis of the data been provided? Is it appropriate?

F1 Yes F2 No

Clinical significance Was the magnitude of the observed effect of the observed treatment effect clinically significative?

F1 Yes F2 No

After the presentation of the criteria, it should be noted that the given data are adapted to the evaluated product since it has obtained the maximum grade to all the criteria. The data where generated with the prosthesis as the object of evaluation, used with the intended purpose, and the information has been collected from a representative number of the population (<99 people per monitoring report, with a women ratio of 4.5:1 with respect to men, although the average age is not mention) and a consistent diagnosis for which the patients were intervened, maintaining a similar percentage both in the main diagnosis (gonarthrosis) and the radiological grade (Alhbach stages). In terms of data contribution to assure the functionality and the safety of the prosthesis follow the same trend, with exception of a statistical analysis. It is important to point out that the study design was appropriate because the relevant patient information, the radiology and the clinical evaluation in the preoperative were considered:

Side of the implantation Carry other prosthesis Arthroplasty in other articulation Diagnosis

Performance of the extremity Joint Balance Anatomical joint axis (varus/valgus) Gonarthrosis stage (Alhback) Knee Score (KS) Functional Knee Score (FS)

Detailed information of the intervention and of the used implants has been given: Approach used

Other surgical gestures Retention or removal of the posterior cruciate ligament Preoperative incidence Implants size Cemented/ Non-cemented Number of screws to fix the tibial plate Utilization of bone graft and type Tibial polyethylene thickness Substitution and size of the kneecap, when appropriate

Post-surgical information was given, distinguishing between the immediate postoperative and the monitoring review: Immediate postoperative: o Immediate prostoperative radiology (angles in projection anteroposterior and mediolateral) o Postoperative complications o Average stay in hospital Monitoring

o Subjective evaluation o Objective evaluation (VAS, KS, FS) o Radiological monitoring o Radiolucency zone in the lateral femur, tibia in AP, lateral tibia and axial kneecap o Complications

In view of the monitoring repots (Appendix I) the results show the functionality expected for the knee prosthesis in terms of pain and mobility improvement, using objective criteria (VAS, KS and FS).

The monitoring duration was enough, since the four monitoring reports collected information with a minimum of 5 years evolution, so the typical complications of this kind of intervention may also be evaluated (commented with more detail in point 1.6) The only criterion that is not seen in the reports is the data statistical treatment. However, as this is not a clinical investigation, and as this is a prosthesis with widely settled technology, is justified the use of qualitative results. Is also worth pointing out that in the monitoring reports survival is not evaluated, because the total number of implanted prosthesis in the same period in the hospital or the number of revision made couldn’t be obtained. Nevertheless, Traiber which commercialize the Excel prosthesis since 1995, claim the sale of almost 1000 prosthesis a year and haven’t had any complaints related to them.

1.6 DATA ANALYSIS The objective of the data analysis phase is to determine if the previous evaluated data for the knee prosthesis demonstrate the clinical functionality and safety of the product in relation with its intended use.

1.6.1 Functionality

The most relevant data in the contribution of the group functionality demonstration are observed in objectives variables like in a visual analog pain scale (VAS), in the Knee score (KS) and in the Functional Knee Score (FS). It is also important to take in account the actions taken in the intervention that, in group, have allowed the achievement of that functionality. The relevant measures taken in the surgical interventions can be summarized in the following way:

Most of the surgeries where performed by medial approach and the posterior cruciate ligament was maintained. In a few opportunities the knee extensor system was performed in to get kneecap dislocation. About the used implants in a femoral level, around the 55% were size 1, and around the 80% between size 1 and 2.

In the tibial implants used approximately the 85-90% were sizes 1 and 3, with similar proportions. The kneecap was replaced in approximately 60% of the cases, equally distributed between the three sizes. The polyethylene insert used was between 8 and 10 mm thickness in 70% of the cases.

Chart 4. With the conditions above the following objective values in the functionality improvement have been achieved:

Year of the report

Improvement KS

KS excellent

KS good Improvement FS

FS excellent

FS good VAS

2003 33.9% 27.5% 66.7% 27.2% 57.5% 21.5% 1.45 2004 33.9% 27.5% 66.7% 27.3% 57% 21% 1.48 2005 33.9% 27.3% 66.8% 27.3% 57.3% 21% 1.46 2006 33.9% 27.1% 66.8% 27.3% 57.2% 21% 1.45

Considering the results showed in Chart 4, it can be said that the evaluated prosthesis offer good performance and improved functionality, reflected in the objective variables based in Knee Society (KS and FS). The visual analog scale (VAS) gives one more thing about the low pain prevalence in patients with TKP. 1.6.2. Safety In terms of safety, should be noted the monitoring period with 5 years minimum of evolution, the number and the exposed patients’ characteristics to the knee arthroplastia intervention with the Excel prosthesis. The number of patients in each monitoring group is significant, it was always over 99 patients, and a representative sample of the population in which the treatment is provided (women/men ratio of 4:1 and, although the age is not explicit mention, the symptoms and the number of arthrtoplasties and arthroplasties in other articulation confirm that this is a population with an average of over 65 years old). The clinical condition is also shown as representative and consistent, 94% of cases presented gonarthrosis and consistent distribution of the percentages in the five stages of Alhbach (25, 10, 25,30 and 10% respectively) in all the reports.

Another remarkable chapter in the prosthesis security section is linked to adverse events or complications that came along the monitoring:

Preoperative incidences:

o Accidental patellar tendon detachment of the TTA (≤ 2 %) o Insignificant minor incidences (≤ 3 %)

Inmediate postoperative:

o Superficial infections that were resolved without affecting the prosthesis(≤ 3 %)

From the postoperative radiographic monitoring and the attached monitoring in the Appendix I, it can be affirmed that there is a tendency to variation of the studied angles between the immediate postoperative and the monitoring after 5 years, which represent a good integration and components performance. It is important to mention the appearance of major radiolucencies in the tibial components. However, it does not seem to have a direct relation with the clinical loosening of components appearance, as it was confirmed with the radiological monitoring. And this is because of the appearance of such radiolucencies in zones 1, 2, 3 and 4 and no in zones corresponding to the tibial keel (5, 6 and 7). In light of the presented, no adverse effects are beyond of what could be expected in a knee arthroplasty. So that, the established security characteristics in the technical documentation of Traiber and the terms of use with reference to the surgeon experience in this kind of surgery limits any security risk.

1.6.3. Product information and instructions for use

In view of the risk analysis document of Traiber, it should be noted that the actions taken to reduce risks cover what demonstrates the clinical experience, indicated in the instructions for use:

Danger associated to the inappropriate use of an instrument Danger associated to the inappropriate use by the patient (not respecting the limitations after the implantation) It is also recommended to the doctor provide information to the patient regarding rehabilitation.

1.7. CONCLUSIONS The conclusions that can be reached about functionality and safety of the knee prosthesis Excel of Traiber after the evaluation of the provided monitoring data, with respect of the terms of use for the prosthesis using the specific instrument provided by Traiber, are summarized as following:

The prosthesis serves as the manufacturer intended. The provided data evidence shows approval with the Relevant Essential Requirements (see Traiber’s documentation). The prosthesis is not a risk for the security under the intended use. Prosthesis functionality and safety have been showed with objective variables. Risks associated with the use of the prosthesis are acceptable, being the benefit/risk balance.

APPENDIX I

• Protocol for the total knee arthroplasties monitoring

• Monitoring reports (2003, 2004, 2005 and 2006): “Review of the group evolution with total knee prosthesis (TKP) for more than 5 years Traiber’s Excel”

PROTOCOL FOR THE TOTAL KNEE ARTHROPLASTIES MONITORING

CENTER NAME ___________________________________________________________________ TYPE OF CENTER GENERAL HOSPITAL [ ] REGIONAL HOSPITAL [ ] PRIVATE CLINIC [ ] UNIVERSITY HOSPITAL [YES] [NO] NUMBER OF KNEE PROSTHESIS PER YEAR IN THE CENTER [ ] NUMBER OF SURGEONS IMPLANTING THE PROSTHESIS [ ] SURGEON IMPLANTING THE PROSTHESIS NUMBER OF PROSTHESIS / AVERAGE YEAR [ ] PATIENT BIRTH DATE ___ / _____________ / _______ SEX [MALE] [FEMALE]

SURVIVAL CONTROL

MONITORING PERIOD [ ] months TOTAL NUMBER OF PROSTESIS [ ]

N° ASSESSED PROSTHESIS [ ] N° NON-ASSESSED PROSTHESIS [ ]

NON-ASSESSMENT CAUSES [ ]

NUMBER OF PROSTHESIS [ ]

5. Cause (description) Number

PRE-OPERATION PATIENT IMPLANTATION SIDE [ ] RIGHT [ ] LEFT THE PATIENT HAS ANOTHER PROSTHESIS [YES] [NO] HIP HOMOLATERAL [ ] CONTRALATERAL [ ] KNEE HOMOLATERAL [ ] CONTRALATERAL [ ] THE PATIENT HAS AN ARTHROPATY IN OTHER ARTICULATION [YES] [NO] HIP HOMOLATERAL [ ] CONTRALATERAL [ ] KNEE HOMOLATERAL [ ] CONTRALATERAL [ ] PRE-OPERATIVE DIAGNOSIS [ ] EXTREMITY ATTITUDE ___________________________________________________________________ ARTICULAR BALANCE FLECTION [ ] degrees EXTENSION [ ] degrees PRE-OPERATIVE RADIOLOGY ANATOMIC AXIS VARUM [ ] degrees VALGUM [ ] degrees GONARTHROSIS STAGE (Alhback) [ ]

PRE-OPERATIVE CLINICAL EVALUATION CLINICAL SCORING PAIN WHEN WALKING [ ] WHEN GOING UPSTAIRS - DOWNSTAIRS [ ] MOBILITY RANGE [ ] STABILITY MEDIUM-LATERAL [ ] ANTERO-POSTERIOR [ ] DEDUCTIONS LACK OF EXTENSION [ ] CONTRACTURE WHEN FLECTING [ ] ALIGNEMENT DEFECT [ ] PAIN IN REST [ ] TOTAL [ ] FUNCTIONAL SCORE WALKING PERIMETER [ ] GOING UPSTAIRS [ ] GOING DOWNSTAIRS [ ] STAND UP FROM CHAIR [ ] DEDUCTIONS [ ] TOTAL [ ]

INTERVENTION DATE OF THE PATIENT'S INTERVENTION ___/_______/_____ TYPE OF APPROACH USED (arthrotomy) LATERAL [ ] MEDIAL [ ] OTHER SURGICAL MANAGEMENT SECTION OF THE QUADRICEPS TENDON [ ] TIBIA OSTEOTOMY [ ] POSTERIOR CRUCIATE LIGAMENT KEPT [ ] REMOVED [ ] PRE-OPERATIVE INCIDENCES

USED IMPLANTS FEMORAL TYPE ____________________________________________ SIZE [ ] CEMENTED (YES][NO] POSTERO-STABILIZED [YES] [NO] TIBIAL TYPE ____________________________________________ SIZE [ ] CEMENTED (YES][NO] FIXATION SCREWS [YES] [NO] NUMBER [ ] BONE GRAFT [YES] [NO] AUTOLOGOUS [ ] HOMOLOGUE [ ] TIBIAL POLYETHYLENE THICKNESS [ ] mm. POSTERO-STABILIZED [YES] [NO] PATELLA PATELLAR REPLACEMENT [YES] [NO] SIZE SMALL [ ] MEDIUM [ ] LARGE [ ]

IMMEDIATE POST-OPERATIVE POST-OPERATIVE RADIOLOGY IMMEDIATE Rx IN AR PROJECTION ANGLE α [ ] degrees ANGLE β [ ] degrees TOTAL ANGLE Ω [ ] degrees Rx IN LATERAL PROJECTION FEMORAL FLECTION (ANGLE γ) [ ] degrees TIBIAL SLOPE (ANGLE σ) [ ] degrees POST-OPERATIVE COMPLICATIONS (before medical discharge) NONE [ ] INFECTION SUPERFICIAL [ ] DEEP [ ] PATELLAR DISLOCATION [YES] [NO] FEMORO-TIBIAL DISLOCATION [YES] [NO] OTHER COMPLICATIONS MEDICAL DISCHARGE DATE ____/_______________/______

MONITORING ASSESSMENT DATE OF MONITORING ___/_______________/______ SUBJECTIVE ASSESSMENT PAIN BETTER MOBILITY BETTER HAPPY YES UNCHANGED UNCHANGED NO WORSE WORSE OBJECTIVE ASSESSMENT SCORE IN ANALOGIC PAIN SCALE [ ] CLINICAL SCORING PAIN WHEN WALKING [ ] WHEN GOING UPSTAIRS - DOWNSTAIRS [ ] MOBILITY RANGE [ ] STABILITY MEDIUM-LATERAL [ ] ANTERO-POSTERIOR [ ] DEDUCTIONS LACK OF EXTENSION [ ] CONTRACTURE WHEN FLECTING [ ] ALIGNEMENT DEFECT [ ] PAIN IN REST [ ] TOTAL [ ] FUNCTIONAL SCORE WALKING PERIMETER [ ] GOING UPSTAIRS [ ] GOING DOWNSTAIRS [ ] STAND UP FROM CHAIR [ ] DEDUCTIONS [ ] TOTAL [ ]

RADIOLOGICAL MONITORING IMMEDIATE Rx IN AR PROJECTION ANGLE α [ ] degrees ANGLE β [ ] degrees TOTAL ANGLE Ω [ ] degrees Rx IN LATERAL PROJECTION FEMORAL FLECTION (ANGLE γ) [ ] degrees TIBIAL SLOPE (ANGLE σ) [ ] degrees RADIOLUCENCY ZONES LATERAL FEMUR TOTAL [ ] TIBIA IN AP TOTAL [ ] LATERAL TIBIA TOTAL [ ] AXIAL PATELLA TOTAL [ ]

1 2 3 4 5 6 7

1 2 3 4 5 6 7

1 2 3

1 2 3

COMPLICATIONS FEMUR - TIBIA- PATELLA _______________________________________ COMMENTS

REVIEW OF A 5 YEARS EVOLUTION GROUP TREATED WITH EXCEL (TRAIBER) TOTAL KNEE PROSTHESIS

Formalized by:

Sant Joan UNIVERSITY HOSPITAL

Antonio Ruiz Guillén, M.D.

COT Serv. Chief, Univ. Hosp. "Sant Joan", Reus

June 2003


A total of 99 medical records of operated patients with Excel TKP (TRAIBER) have been revised with a minimum of 5 years evolution which have been obtained from a teaching activity hospital. This research evaluates the evolution of these 99 knee prosthesis, both for the radiological point of view and the clinical one. Survival is not evaluated since the total number of implanted prosthesis and the number of reviews carried out have not been obtained during the same period of time at the hospital. A retrospective survey has been done. To evaluate the radiological and clinical results, the criteria of Knee Society has been used: - Knee Society Clinical Rating System - Knee Society Roetgenographic Evaluation System

The 119 prosthesis correspond to 23 men and 76 women 56 right knees and 43 left knees have been implanted In 14 cases, the patient had another arthroplasty Hip 2 ( 1 ipsilateral, 1 contralateral) Knee 12 Patients showed arthropathy in other joint in 53 cases: Hip 3 Knee 50 The diagnosis by which the patients were operated was: Primary Gonarthrosis 93 Rheumatoid arthritis 2 Post-traumatic arthrosis 2 Others 2 The limb performance before surgery was: Normo-axis 13 cases Varum 54 cases Genu varum 19 cases Valgum 13 cases Balanced articulation previous to the surgery was: Partial flexion of 104, 69º (min. 55ª, max. 135º) Extension affected in 44 patients Mean of -10, 6º Minimum of -5º Maximum of -30º

The Pre-operative radiology showed: 79 patients with a varum of 8, 00º mean 7 patients with a valgum of 6, 20º mean 13 patients without variation of mechanical axis The radiological degree of arthrosis by which the kees were operated was (Alhbach): Stage 1 24 cases Stage 2 12 cases Stage 3 25 cases Stage 4 29 cases Stage 5 9 cases The Pre-operative clinical evaluation (Knee Society) was the following: Total clinical score (Knee Score) 45, 10 Total functional score (Functional Score) 50, 25 INTERVENTION 97 Medial approaches and two Lateral approaches were used. During the surgery the following was accomplished: 2 sections of quadriceps tendon 5 TTA osteotomies 6 lateral retinaculum release 8 previous surgery material removals Posterior cruciate ligament was maintained in 96 cases and removed in 3 cases. 4 Pre-operative events happened: 2 accidental disinsertions of TTA patellar tendon 2 insignificant minor events

Implants used - Femoral level 99 cemented Size: 0 (12), 1 (54), 2 (25), 3 (8) In 54 cases, screws were used to fix the implant. Size: 0 (2), 1 (41), 2 (48), 3 (7), 4 (1) Polyethylene In 1 case, one subsequently stabilized was used 6mm (12), 8 mm (38), 10 mm (32), 12 mm (11), 15 mm (6) Kneecap

Only in 54 cases was replaced

- 18 small

- 20 medium

- 16 big

In one opportunity, autologous bone graft was used

IMMEDIATE POST-OPERATIVE Radiology - In AP projection (medium) Angle α 97,25 Angle β 89,23 Angle Ω 186,67 - In lateral projection (médium) Angle γ 4,82 Angle σ 88,70 The following complications have been informed: 2 superficial infections cured without affecting the prosthesis Other complications not directly related with the implant

The average stay was 10 days, with a minimum stay of 6 days and a maximum stay of 28 days (Standard deviation 3, 82) Monitoring Average monitoring of 69,50 months Maximum monitoring 72 months Minimum monitoring 67 months Subjective evaluation In terms of pain, patients recognize that they feel: Better 98 patients (98,98%) Unchanged 1 patient (1,01%) No patient has recognized to be worse than before surgery In terms of mobility Better 47 patients (47,47%) Unchanged 37 patients (37,37%) Worse 15 patients (15,16%) 98 out of 99 patients appoint to be happy with the result, and only 1 of them says she/he was not happy.

Objective evaluation According to the visual analog scale (VAS), mean result of monitoring has been 1,45 Score according to Knee Society Total Knee Score 78,80 Total Functional Score 77,30

Radiological monitoring - In AP projection: Angle α 97,80 Angle β 89,18 Angle Ω 186,77

- In lateral projection (medium) Angle γ 4,82 Angle σ 89,50 Radiolucency zones - Femoral level (lateral projection) Radiolucency lines have been observed in 41 cases (41,41%). They are distributed as follows:

Zone 1 2 3 4 5 6 7

Cases 6 31

12

8 58

13

20

With an average obtained from the addition of radiolucencies per implant of 2,07 mm, ordered as follows: 17 cases 1 mm 9 cases 2 mm 8 cases 3 mm 5 cases 4 mm 1 case 5 mm 1 case 6 mm - Tibial level (AP projection) The presence of radiolucent lines has been observed in 41 cases (41,41%), distributed as follows:

Zone 1 2 3 4 5 6 7

Cases 26

22

21

23

22

11

13

With an average of the sum of radiolucency per implant of 3,54 mm, distributed as follows: 6 cases 1 mm 10 cases 2 mm 5 cases 3 mm 6 cases 4 mm 1 case 5 mm 5 cases 6 mm 1 case 7 mm 2 cases 8 mm 2 cases 9 mm 1 case 10 mm 1 case 11 mm 1 case 12 mm -Tibial level (In lateral projection) The presence of radiolucency has been observed in 36 cases (36,36%), registered as follows:

Zone 1 2 3

Cases 27 19 7

With an average of the sum of radiolucencies per implant of 1,60 mm, distributed as follows: 17 cases 1 mm 12 cases 2 mm 4 cases 3 mm 2 cases 4 mm 1 case 6 mm - Kneecap level (in axial projection) No case of radiolucency has been observed.

EVALUATION OF RESULTS Introduction The data only pretend to describe the result of the studied prosthesis in functionality (objective, subjective) and it`s radiological result. The survival of the prosthesis is not evaluated since it cannot be counted on the total number of implants in the studied period of time nor the number of examined prosthesis in the same period. Objective Results The most important improvement is about the pain, with 98,98% of the patients recognizing improvement. It is not the same with mobility, where only a 47,47% recognize improvement. Nevertheless, 98,98% of patients declare being happy with the obtained result after surgery. The visual analog pain scale (VAS), provides one more datum about little prevalence of pain in patients with TKP. The result based in Knee Score and Functional Score of the Knee Society shows a considerable improvement in patient.

Total clinical Score (Knee Score) Pre-operative 45,10 Post-operative 78,70 Improvement 33,90 % Total functional score (Functional Score) Pre-operative 50,31 Post-operative 77,14 Improvement 27,32% The post-operative result shows the following outcomes: -Knee Score - 27,50% Excellent - 66,70% Good - 5,80% Regular -No bad result With 94,20% between Excellent and Good outcomes - Functional Score - 57,50% Excellent - 21,50% Good - 11% Regular - 10% Bad With 79% between Excellent and Good outcomes. Almost all the surgeries were by medial approach and the posterior cruciate ligament was kept. There was rarely an intervention on the knee extension system to achieve the kneecap dislocation (3 times).

In only 4 times it was necessary a release of the external patellar aileron to keep it centered in the flexion and extension. In only 2 occasions an avulsion- detachment of the distally patellar ligament has been reported and was resolved reembedding it with staples. About the used implants in femoral level, 54,54% have been of size (1) and 79,79% between (1) and (2). In the tibia, 89,89% are sizes (1) and (2), almost equally. The kneecap was replaced only in 54 cases, distributed equally between the three sizes. The polyethylene used had a thickness between 8 and 10 mm in the 70,70% of cases. Post-operative radiology

α

Postoperatoria

97,25

Seguimiento

97,80

Β

89,23

89,18

Ω

186,67

186,77

γ

4,82

4,82

σ

88,70

89,50

There is not a tendency to variation of the studied angles between the immediate post-operative and the monitoring after 5 years, which present a good integration and performance of the components. About the radiolucencies, it should be noted the appearance of a larger number of them and, particularly, of greater importance in the tibial components. Although is also true that it doesn’t seem to have a direct relation with the clinical appearance of the loosening of component, especially if one takes into account that the appearance of the major radiolucencies have occurred in zone 1,2,3,4 and no in the zone corresponding to the keel (5,6,7).

Conclusion Considering the results, the studied prosthesis provides a good performance, specially, for the pain improvement, with outcomes between excellent and good. 94,20% in Knee Score and 79% in Functional Score.


Formalized by:




July 2004

MONITORING OF MORE THAN FIVE YEARS OF EVOLUTION OF AN EXCEL TRAIBER

TOTAL KNEE PROSTHESIS (TKP) GROUP.

104 Records of patients operated on Excel TKP (TRAIBER) have been checked, all

of them with a five-year minimum evolution, this was obtained from a hospital

that gives teaching activities.

104 knee prosthesis evolutions are evaluated in this study, from a radiological

and clinical point of view.

Survival of the prosthesis has not been evaluated, because neither the total

number of implanted prosthesis in the same period at the hospital nor the

numbers of performed revisions have been obtained. It is a retrospective study.

To evaluate clinical and radiological results it has been used criteria of the Knee

Society:

- Knee Society Clinical Rating System

- Knee Society Roetgenographic Evaluation System

104 prosthesis correspond to 23 men and 81 women.

58 prosthesis correspond to right knees and 46 to left ones. In 10 cases, patients already had another arthroplasty: Hip 2 (1 homolateral, 1 contralateral) Knee 8

In 57 cases, patients suffered from arthropathy in another major articulation:

Hip 3

Knee 54 Diagnosis of the operated patients:

Primary gonarthrosis 99

Rheumatoid Arthritis 2

Post-raumatic Arthrosis 1

Others 2

Posture of the extremity before the surgery:

Normo-axis 13 cases

Genu varum 56 cases Genu

varum-flexum 21 cases Genu

valgum 14 cases

Articulation balance before the surgery:

Average Flexion 104.80º (min. 55º, max. 135º)

Affected extension in 35 patients

Average –10.6º

Minimum –5º

Maximum –30º

Preoperative radiology presented:

86 patients with an 8.00º genu varum Average

7 patients with a 6.20º genu valgum Average

11 patients presented no variation on the mechanical axis.

Radiological arthrosis degree of the operated knees was (Alhbach):

Degree 1 25 cases

Degree 2 13 cases

Degree 3 26 cases

Degree 4 30 cases

Degree 5 10 cases

Preoperative clinical evaluation (Knee Society) was:

Total clinical score (Knee Score) 45.10

Total functional score (Functional Score) 50.28

OPERATION

102 medial approaches and 2 lateral approaches were used.

During the surgery were carried out:

1 section of the quadriceps tendon

4 TTA osteotomy

3 external patellar aileron releases

6 removals of previous surgery material

Posterior cruciate ligament was removed in 1 case and preserved in 103 cases.

There have been 4 preoperative incidences:

1 accidental disinsertion of the TTA patellar ligament

2 insignificant minor incidences

Used implants

- At femoral level:

104 cemented implants

Size:

0 (14), 1 (57), 2 (25), 3 (8)

- At tibial level:


In 49 cases there were used screws to secure the implants.

Size:

0 (3), 1 (42), 2 (49), 3 (9), 4 (1)

Polyethylene:

One subsequently stabilized was used in 1 case

6 mm (13), 8 mm (40), 10 mm (34), 12 mm (12), 15 mm (5)

Patella

Was replaced in 65 cases

- 20 small

- 22 medium-sized

- 23 large

In 1 case there was used an autologous bone graft.

IMMEDIATE POSTOPERATIVE

Radiology

- AP projection (average)

Angle α

97.28

Angle β

89.26

Angle Ω

186.70

- Lateral projection (average)

Angle γ 4.79

Angle σ 88.73

There have been informed the following complication:

2 superficial infections which were solved without

causing any impact over the prosthesis

Other complication which were not directly related to

the implant

The average term was 10 days, minimum term was 6 days and maximum term

was 28 days (standard deviation: 3.81)

MONITORING

Average monitoring: 69.35 months

Maximum monitoring: 72.10 months

Minimum monitoring: 66.60 months

Subjective evaluation

In relation to the pain, patients confirmed that they feel:

Better 101 patients (97.11 %)

The same 3 patients (2.88 %)

No patient has confirmed to be worst than before the surgery

Concerning to mobility: Better 52 patients (50.00 %)

The same 37 patients (35.57 %)

Worst 15 patients (14.43 %)

From 104 patients, 101 declared to be pleased with the results, and just 3

affirmed they are not (From these 3 patients, just one of them corresponds to

objective evaluation).

Objective evaluation

According to the Visual Analogue Scale of pain (VAS), monitoring average result

was 1.48

Score according to Knee Society

Total Knee Score 78.80

Total Functional Score 77. 27

Radiological monitoring

- AP Projection

Angle α 97.72

Angle β 89.13

Angle Ω 186.76


Angle γ 4.79

Angle σ 89.82

Radiolucent zones

- At femoral level (lateral projection)

It has been observed the presence of radiolucent lines in 51 cases

(49.03%), distributed as follows:

Zone 1 2 3 4 5 6 7

Cases 6 37 21 19 71 13 19

2.15 mm is the average of the sum of radiolucencies per implant, which is

distributed as follows:

21 cases 1 mm

12 cases 2 mm

8 cases 3 mm

8 cases 4 mm

1 case 5 mm

1 case 6 mm

- At tibial level (AP Projection)

It has been observed the presence of radiolucent lines in 49 cases

(47.11%), distributed as follows:

Zone 1 2 3 4 5 6 7

Cases 28 28 23 27 25 17 15

3.54 mm is the average of the sum of radiolucencies per implant, distributed as

follows:

6 cases 1 mm

14 cases 2 mm

6 cases 3 mm

7 cases 4 mm

3 cases 5 mm

6 cases 6 mm

1 case 7 mm

2 cases 8 mm

1 case 9 mm

1 case 10 mm

1 case 11 mm

1 case 12 mm

- At tibial level (lateral projection) It has been observed the presence of radiolucency in 42 cases

(41.17%), registered as follows:

Zone 1 2 3

Cases 30 26 7

1.70 mm is the average of the sum of radiolucencies per implant, distributed as

follows:

20 cases 1 mm

14 cases 2 mm

5 cases 3 mm

2 cases 4 mm

1 case 6 mm

- At level of the patella (axial projection)

It has not been observed any case of radiolucency

EVALUATION OF THE RESULTS Introduction

Data just expect to describe the results of the studied prosthesis, based on

functionality (objective, subjective) and radiological results.

Prosthesis survival has not been evaluated, because it is not possible to count

neither the total number of implanted prosthesis in the studied period nor the

number of revised prosthesis in the same period.

Objective Results

Most important improvement is obtained in relation to the pain, 97.11% of the patients affirm they have improved.

Nevertheless, in relation with the mobility, only a 50.00% of the patients affirm

they have improved.

Despite this, 97.11% of the patients declare to be satisfied with surgery results.

Visual Analogue Scale of pain (VAS) provides a piece of information about low

pain prevalence in TKP patients.

The Knee Score and Functional Score based result presented a substantial improvement on the patients.

Total clinical score (Knee Score) Preoperative

45.10

Postoperative 78.66

Improvement 33.90%

Total functional score (Functional Score)

Preoperative 50.25

Postoperative 77.10

Improvement 27.35%

Postoperative result presents the following results:

- Knee Score

- 27.50 % Excellent

- 66.70% Good

- 5.80% Regular

- No unsatisfactory result

94.20% between excellent and good results

- Functional Score

- 57.00 % Excellent

- 21.60% Good

- 11.20% Regular

- 10.20% Unsatisfactory

78,60% between Excellent and Good results.

Most of the surgeries were carried out by medial approach and posterior

cruciate ligament was preserved.

Intervention over the knee extensor mechanism to obtain patellar dislocation

was rarely (2 interventions).

External patellar aileron release to keep it centered in the flexion and extension

was required only in 2 opportunities.

Only in 1 occasion was notified a distally extraction and disinsertion of the

patellar ligament, which was resolved through installing staples.

In relation to used implants at femoral level, 54.80% have been of size (1) and

78.84% between (1) and (2).

In the tibia, 87.50% corresponds to size (1) and (2), almost equally.

Patella was replaced only in 65 cases, divided homogeneously in three sizes.

In the 71.15 % of the cases, polyethylene thickness was between 8 and 10 mm.

Postoperative radiology

α

Postoperative

97.28

Monitoring

97.72

β

89.26

89.13

Ω

186.70

186.76

γ

4.79

4.79

σ

88.73

89.82

It can be appreciated that there is no tendency to variation of the studied angles

between the immediate postoperative and the 5 years monitoring. This showed

a good integration and behaviour of the components.

Regarding radiolucencies it is worth to point out the appearance of a larger

number of them, and mainly, the importance in tibial components. Nevertheless,

it is also true that it does not seem to have a very direct relation with the clinical

appearance of component loosening, especially if it is taking into account that

the appearance of greatest radiolucency was in 1,2,3,4 zones and not in the keel

zone (5, 6, 7).

Conclusion

According to the results, it can be said that studied prosthesis offer a good

behaviour, mainly, in relation to the pain relief, presenting excellent and good

results of 94.20% in Knee Score and 78.60% in Functional Score.


Formalized by:




July 2004


TOTAL KNEE PROSTHESIS (TKP) GROUP.

119 Records of patients operated on Excel TKP (TRAIBER) have been checked, all of

them with a five-year minimum evolution obtained from a hospital that give

teaching activities.

119 knee prosthesis evolutions are evaluated in this study, from a radiological and

clinical point of view.

Survival has not been evaluated, because neither the total number of implanted

prosthesis in the same period at the hospital nor the numbers of performed

revisions have been obtained. It is a retrospective study.

Criteria of the Knee Society have been used to evaluate clinical and radiological

results:



119 prosthesis correspond 28 men and 91 women.

66 prosthesis correspond to right knees and 53 to left ones. In 17 cases, patients already had another arthroplasty: Hip 2 (1 homolateral, 1 contralateral) Knee 15

In 72 cases, patients suffered from arthropathy in another major articulation:

Hip 5

Knee 67

Diagnosis of the operated patients:


Rheumatoid Arthritis 3

Post-raumatic Arthrosis 1

Others 3

Posture of the extremity before the surgery:

Normo-axis 15 cases

Genu varum 64 cases Genu

varum-flexum 24 cases Genu

valgum 16 cases

Articulation balance before the surgery:

Average Flexion 104. 69º (min. 55º, max. 135º)


Average –10.6º

Minimum –5º

Maximum –30º

Preoperative radiology presented:

93 patients with an 8.00º genu varum Average

9 patients with a 6.20º genu valgum Average

17 patients presented no variation on the mechanical axis.

Radiological arthrosis degree of the operated knees was (Alhbach):

Degree 1 29 cases

Degree 2 15 cases

Degree 3 30 cases

Degree 4 34 cases

Degree 5 11 cases

Preoperative clinical evaluation (Knee Society) was:



OPERATION

118 medial approaches and 1 lateral approach were used.

During the surgery were carried out:

2 sections of the quadriceps tendon

5 TTA osteotomy

6 external patellar aileron releases

8 removals of previous surgery material

Posterior cruciate ligament was removed in 3 case and preserved in 116 cases.

There have been 4 preoperative incidences:

2 accidental disinsertion of the TTA patellar ligament

2 insignificant minor incidences

Used implants

- At femoral level:


Size:

0 (16), 1 (64), 2 (30), 3 (9)

- At tibial level:


In 67 cases there were used screws to secure the implants.

Size:

0 (4), 1 (47), 2 (56), 3 (11), 4 (1)

Polyethylene:

One subsequently stabilized was used in 3 cases

6 mm (15), 8 mm (46), 10 mm (38), 12 mm (14), 15 mm (6)

Patella

Was replaced in 76 cases

- 23 small

- 25 medium-sized

- 28 larg

In 2 cases there was used an autologous bone graft.

IMMEDIATE POSTOPERATIVE

Radiology

- AP projection (average)

Angle α

97.30

Angle β

89.28

Angle Ω

186.72


Angle γ 4.81

Angle σ 88.75

There have been informed the following complication:

2 superficial infections which were solved without

causing any impact over the prosthesis

Other complication which were not directly related to

the implant

The average term was 10 days, minimum term was 6 days and maximum term

was 28 days (standard deviation: 3.80)

MONITORING

Average monitoring: 69 months

Maximum monitoring: 72.01 months

Minimum monitoring: 66.50 months

Subjective assessment

Patients recognize that about the pain they feel:

Better 117 patients (98.31%)

No change 2 patients (1.69%)

No patients have recognized feeling worse than before surgery

Regarding mobility:



Worse 18 patients (15.12%)

Of 119 patients, 117 said that they are pleased with the results and only two of them

said that they are not (one of these two cases correspond with objective assessment).

Objective assessment

According to Visual Analog Scale (VAS), the monitoring average result has been 1.46



Total Functional Score 77.25


- AP projection

Angle α 97.70

Angle β 89.11

Angle Ω 186.74

- Lateral projection (lateromedial)

Angle γ 4.81

Angle σ 89.80

Radiolucent zone

- Femoral level (lateral projection)

It has been observed the presence of radiolucent lines in 58 cases (48.74%), shared out

in the following way:

Zone 1 2 3 4 5 6 7

Cases 6 41 22 10 78 14 21

With an average of the total amount of the radiolucencies per implant of 2.18 mm,

shared out this way:

25 cases 1 mm

13 cases 2 mm

9 cases 3 mm

8 cases 4 mm

2 cases 5 mm

1 case 6 mm

- At tibial level (AP projection)



Zone 1 2 3 4 5 6 7

Cases 30 29 24 27 26 16 18

With an average of the total amount of radiolucency per implant of 3.58 mm, shared out in this way:

8 cases 1 mm

17 cases 2 mm

6 cases 3 mm

7 cases 4 mm

3 cases 5 mm

7 cases 6 mm

1 case 7 mm

2 cases 8 mm

2 cases 9 mm

1 case 10 mm

1 case 11 mm

1 case 12 mm

- At tibial level (lateral projection)

It has been observed the presence of radiolucent lines in 49 cases (41.17%), organized in this way:

Zone 1 2 3

Cases 34 27 8

With an average of the total amount of radiolucencies per implant of 1.68mm, shared out in this way:

24 cases 1 mm

17 cases 2 mm

5 cases 3 mm

2 cases 4 mm

1 case 6 mm - At patellar level (axial projection) No radiolucency cases have been observed

RESULTS ASSESSMENT

Introduction

These data just expect to describe the prosthesis result studied as regards usefulness

(objective, subjective) and their radiological result.

Prosthesis survival is not assessed considering that is not possible to count the total

amount of implants in the period of time in which this study was made neither the

number of prosthesis checked in the same period.

Objective results

The main improvement was obtained regarding pain. 98.31% of patients recognize

having benefits.

It is not the same with mobility. Only 48.74% recognize having benefits.

Nevertheless, 98.31% of patients affirm they are pleased with this surgery.

Visual Analog Scale (VAS) provides more information about little prevalence of pain in

patients with a Total Knee Prosthesis.

Based on Knee Score and Functional Score results by Knee Society there is considerable

improvement of patients.

Total clinical score (Knee Score)

Pre-operative period 45.09

Post-operative period 78.68

Improvement 33.88%




Improvement 27.29%

Post-operative result shows the following results:

- Knee Score

- 27.30 % Excellent

- 66.80% Good - 5.90% Regular - No bad results

94.10% between Excellent and Good results

- Functional Score

- 57.30 % Excellent

- 21.30% Good

- 11.40% Regular

- 10% Bad


Most of surgeries were performed by medial approach and posterior cruciate ligament

was conserved.

In few opportunities performances were required over knee extension system in order

to get patellar dislocation (three opportunities).

Only in four opportunities patellar external aileron liberation was needed in order to

keep it centered on flexum-extension.

Only in two opportunities a patellar ligament avulsion-disinsertion distally was

informed and solved with staple reembedding.

Regarding femoral implants 53.78% were size (1) and 78.99% between size (1) and (2).

86.55% of tibial implants were size (1) and (2) almost the same quantity.

Patella was replaced only in 76 cases, shared out uniformly among the three sizes.

Polyethylene had between 8 and 10 mm of thickness in 70.58% of the cases.

Post-operative radiology

α

Post-operative

97.30

Monitoring

97.70 β

89.28

89.11 Ω

186.72

186.74 γ

4.81

4.81 σ

88.75

89.80

It is detected that there is no tendency to angle variation between immediately post-

operative period and the monitoring carried out five years later what demonstrate

good integration and performance of the components.

Regarding radiolucency it is worth pointing out the appearance of a bigger number of it,

and mainly, the importance in tibial components, it is also true though that it does not

seem to have a direct relation with the clinical appearance of component loosening,

especially if it is taking into account that the appearance of greatest radiolucency was in

1,2,3,4 zones and not in the keel zone (5, 6, 7).

Conclusion

Based on the results, studied prosthesis offer a good performance, mainly in regards to

improvement of pain with results between excellent and good. The scores obtained

were 94.10% by Knee Score and 78.60% by Functional Score.


TOTAL KNEE PROSTHESIS (TKP) GROUP

Formalized by:

University Hospital “La Princesa”, Madrid

University Hospital “Sant Joan”, Reus

Antonio Ruiz Guillen, M.D

Service Director COT Hosp. Univ.

“Sant Joan”, Reus

May, 2006

MONITORING OF MORE THAN FIVE YEARS OF EVOLUTION OF AN EXCEL TRAIBER TOTAL

KNEE PROSTHESIS (TKP) GROUP

It has been studied 128 records of patients who have been operated on TKP Excel type

(TRAIBER) with a minimum of five years of evolution. These clinical records have been

obtained from two teaching hospitals.

In this study evolution of these 128 knee prosthesis are assessed, from both points of

view, radiological and clinical.

It is not assessed prosthesis survival since it has not been obtained the total amount of

implanted prosthesis in the same period of time in both hospitals neither the number

of monitoring carried out. This is a retrospective study.

For the assessment of clinical and radiological results Knee Society criteria has been

used:



The 128 Prosthesis belong to 23 men and 105 women.

69 right knees and 59 left knees have been implanted.

In 23 cases the patient was carrier of another arthroplasty.

Hip 4 (1 homolateral, 3 counterlateral)

Knee 19

In 76 cases patients had arthropaty in another major articulation:

Hip 5

Knee 71

The patients were operated for these diagnoses:


Rheumatoid arthritis 3

Post-traumatic arthrosis 1

other 5

The posture of the extremity before surgery was:

Normo-axis 16 cases

Varum 69 cases

Varum-flexum 26 cases

Valgum 17 cases

The balanced articulation before surgery was:

Medial squat of 104.71° (min. 55°, max. 135°)


On average – 10.4°

Minimum – 5°

Maximum – 30°

Pre-operative radiology showed:

97 patients with a varum of 8.04° on average

16 patients with a valgum of 6.24° on average

15 patients without alteration of mechanical axis

Surgeries were carried out when the scale of arthrosis was (Alhbach):

State 1 32 cases State

2 17 cases State 3

30 cases State 4 37

cases State 5 12

cases

Pre-operative clinical assessment (Knee Society) was the following:



SURGERY

126 medial approaches and 2 lateral approaches were used.

During surgery were carried out:

2 sections of the quadriceps ligament

6 anterior tibial tubercle osteotomies (TTOs)

7 liberations of external patellar aileron

9 retreats of previous surgery materials

In 125 cases posterior cruciate ligament was conserved and in 3 cases was removed.

There have been 5 incident pre-operative:

2 accidental disinsertions of the TTO patellar ligament

3 minor incidents, unimportant

Implants used

- At femoral level

49 cemented

79 non- cemented (HAP)

4 stabilized afterwards

Size:

0 (17), 1 (70), 2 (32), 3 (9)

- At tibial level:

76 cemented

52 non- cemented

In 71 cases screws were used to fasten the implant

Size:

0 (4), 1 (51), 2 (60), 3 (12), 4 (1)

Polyethylene:

In 3 cases a stabilized were used afterwards

6 mm (16), 8 mm (48), 10 mm (41), 12 mm (15), 15 mm (8)

Patella

It was replaced only in 84 cases

- 25 small

- 28 medium-sized

- 31 large

Autologous bone graft was used in 2 opportunities.

IMMEDIATE POST-OPERATIVE

Radiology

- AP projection (medial)

Angle α 97.31

Angle β 89.27

Angle Ω 186.69

- Lateral projection (medial)

Angle γ 4.80

Angle σ 88.72

Some complications have been informed:

4 superficial infections that were treated without affecting prosthesis

Others complications without direct relation with the implant

The average stay was 10 days, the minimum were 6 days and the maximum 28 days

(standard deviation: 3.82)

MONITORING

Average monitoring 69.01 months

Maximum monitoring 71.48 months

Minimum monitoring 66.40 months

Subjective assessment

Patients recognize that about the pain they feel:



No patients have recognized feeling worse than before surgery

Regarding mobility:



Worse 21 patients (16.42%)

From 128 patients, 126 said that they are pleased with the results and only two of them

said that they are not (one of these two cases correspond with objective assessment).

Objective assessment

According to Visual Analog Scale (VAS), the monitoring average result has been 1.45



Total Functional Score 77.29


- AP projection

Angle α 97.69

Angle β 89.13

Angle Ω 186.77

- Lateral projection (lateromedial)

Angle γ 4.80

Angle σ 89.83

Radiolucent zones

- At femoral level (lateral projection)



Zone 1 2 3 4 5 6 7

Cases 6 46 25 11 86 14 21

With an average of the total amount of the radiolucencies per implant of 2.23 mm,

shared out this way:

29 cases 1 mm

14 cases 2 mm

10 cases 3 mm

9 cases 4 mm

2 cases 5 mm

1 case 6 mm

- At tibial level (AP projection)



Zone 1 2 3 4 5 6 7

Cases 32 30 25 28 27 17 19

With an average of the total amount of radiolucency per implant of 3.64 mm, shared out in this way:

9 cases 1 mm 22 cases 2 mm 7 cases 3 mm 9 cases 4 mm 3 cases 5 mm 8 cases 6 mm 1 case 7 mm 2 cases 8 mm 2 cases 9 mm 1 case 10 mm 1 case 11 mm 1 case 12 mm

- At tibial level (lateral projection) It has been observed the presence of radiolucency in 55 cases (42.9%), organized in this way:

Zone 1 2 3

Cases 39 30 9

With an average of the total amount of radiolucencies per implant of 1.69 mm, shared out in this way:

27 cases 1 mm 19 cases 2 mm 6 cases 3 mm 2 cases 4 mm 1 case 6 mm

- At patellar level (axial projection)

It has been observed only one case of radiolucency of 2 mm in zone 1

RESULTS ASSESSMENT

Introduction

These data just expect to describe the prosthesis result studied as regards usefulness

(objective, subjective) and their radiological result.

Prosthesis survival is not assessed considering that is not possible to count the total

amount of implants in the period of time in which this study was made neither the

number of prosthesis checked in the same period.

Objective results

The main improvement was obtained regarding pain. 97.65% of patients recognize

having benefits.

It is not the same with mobility. Only 47.65% recognize having benefits.

Nevertheless, 98.4% of patients affirm they are pleased with this surgery.

Visual Analog Scale (VAS) provides more information about little prevalence of pain in

patients with a Total Knee Prosthesis.

Based on Knee Score and Functional Score results by Knee Society there is considerable

improvement of patients.

Total clinical score (Knee Score)



Improvement 33.90%




Improvement 27.31%

Post-operative result shows the following results:

- Knee Score

- 27.1 % Excellent

- 66.80% Good

- 6.1% Regular

- No bad result


- Functional Score

- 57.20 % Excellent

- 21.20% Good

- 11.50% Regular

- 10.10% Bad


Most of surgeries were performed by medial approach and posterior cruciate ligament

was conserved.

In few opportunities performances were required over knee extension system in order

to get patellar dislocation (five opportunities).

Only in six opportunities patellar external aileron liberation was needed in order to

keep it centered on flexum-extension.

Only in two opportunities a patellar ligament avulsion-disinsertion distally was

informed and solved with staple reembedding.

Regarding femoral implants 54.7% were size (1) and 79.70% between size (1) and (2).

86.71% of tibial implants were size (1) and (2) almost the same quantity.

Patella was replaced only in 84 cases, shared out uniformly among the three sizes.

The number of cemented components at femoral level is smaller than at tibial level

(38.3 femoral and 59.4 tibial), with a marked tendency to cement more the tibia than

the femur.

Polyethylene had between 8 y 10 mm of thickness in 69.53% of the cases.

Post-operative radiology

α

Post-operative

97.31

Monitoring

97.69 β

89.27

89.13 Ω

186.69

186.77 γ

4.8

4.8 σ

88.72

89.83

It is detected that there is no tendency to angle variation between immediate post-

operative period and the monitoring carried out five years later what demonstrate

good integration and performance of the components.

Regarding radiolucency it is worth pointing out the appearance of a bigger number of it,

and mainly, the importance in tibial components, it is also true though that it does not

seem to have a direct relation with the clinical appearance of component loosening,

especially if it is taking into account that the appearance of greatest radiolucency was in

1,2,3,4 zones and not in the keel zone (5, 6, 7).

Conclusion

Based on the results, studied prosthesis offer a good performance, mainly in regards to

improvement of pain with results between excellent and good. The scores obtained

were 93.90% by Knee Score and 78.40% by Functional Score.

Excel knee Clinical Studies

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