The Elbow Fixator

Operative Technique by Prof. Dr. D. Pennig and Dr. T. Gausepohl

THE SYMBOL OF CLINICAL RELIABILITY

OORRTTHHOOFFIIXX®

Contents

Introduction page 3

Indications page 3

Design Features page 4

Fixator Assembly page 5

Surgical Technique page 6

Patient Positioning page 6

Fixator Application page 6

Humeral Screw Insertion page 7

Ulnar Screw Insertion page 9

Final Locking of the Fixator page 12

Post-Traumatic Stiffness page 15

Long-Standing Stiffness page 16

Post-Operative Management page 17

Acute Trauma page 17

Post-Traumatic Stiffness page 17

X-rays page 19

Pin Site Care page 19

Fixator Removal page 19

Bibliography page 20

Sterilization page 21

Clinical Cases page 22

Ordering Information page 24

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Introduction

Inadequately treated fracture-dislocations of theelbow with ligamentous instability may cause chronic

pain and permanent disability, thus limiting the useof the upper extremity in those daily activities whichrequire a wide range of flexion and extension at theelbow, and pronation and supination of the forearm.

Traditional revision procedures for these post-traumatic stiff elbows, such as arthrodesis or

arthroplasty, however, are not ideal solutions. Theprimary management of fracture-dislocations of the

elbow with ligamentous instability should, therefore,focus on a good functional outcome.

Accurate reduction and stable fixation of the jointare essential to prevent long-term disability,

but must be coupled with early active motion for the restoration of effective function,

as soon as pain and swelling allow.

The Orthofix Elbow Fixator is a unilateral humero-ulnar external fixation device designed to permit

controlled movement about the centre of rotation ofthe elbow joint. It allows immediate pronation and

supination and early flexion and extension of theforearm, thus preventing post-operative stiffness.

In addition, for controlled distraction of the elbowjoint a small distractor is available, which is normally

placed on the humeral link of the fixator. In flexioncontractures, a small distractor is used initially on

both links to disimpact the articular surfaces,following which a bridging distractor between thelinks may be employed intermittently together with

physiotherapy.

Indications

Indications for the use of the Orthofix Elbow Fixatorinclude:■ Fracture-dislocations with ligamentous instability■ Severely comminuted intra-articular fractures■ Open fractures■ Post-traumatic stiffness 3

Design Features

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The fixator consists of two clamps and two links,with a central connecting unit. The effective lengthof each link can be adjusted by sliding itbackwards or forwards in relation to the centralconnecting unit. Each link can be individuallylocked at the desired length by a link lockingscrew, and the two links can be locked at achosen angle to one another by means of thetriangular knob of the central connecting unit. In addition, for controlled distraction of the elbowjoint a small distractor is available, which isnormally placed on the humeral link of the fixator. To enable the small distractor to be appliedcorrectly, the fixator should be assembled with thehumeral link outside the ulnar link.

Fixator AssemblyThe post is inserted into

the slider unit with thehexagonal fitting on its flatsurface. The link lockingscrew is applied.

The first link is mountedon the slider unit, with thestep on the collar and theAllen wrench fitting point inthe cam facing upwards.The washer is inserted overthe post. The second link isthen applied with the stepfacing downwards and theAllen wrench fitting point inthe cam facing upwards.

The second slider unit ismounted with the screwfitting on the same side asthe first, and: (a) The link locking screw isinserted.(b) The plate is insertedwith its flat surface facingdownwards. (c) The plate locking screw,which is essential forfixator stability, is nowapplied and tightened. (d) The triangular knob isscrewed on.

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d

c

a b

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Surgical Technique

Patient PositioningGeneral or regional anaesthesia should be usedand the patient placed in the supine positionwith the arm on a radiolucent hand table. The arm should be flexed to 90° with theforearm in neutral rotation. The patient’s arm isprepped up to the shoulder and axilla. A tourniquet is not recommended.

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A 2 mm Kirschner wire,150 mm long, is insertedpercutaneously through thecentre of rotation of theelbow joint under imageintensification, and itsposition confirmed in bothplanes. In comminutedfractures, it is sufficient toengage the first cortex only with this wire, whichfunctions as a referencepoint for fixator application.

The central connectingunit is slid over theKirschner wire and thefixator used as its owntemplate for insertion of thescrews. Once the fixatorhas been mounted on the K-wire, the position of thelinks must be adjusted toensure that sufficient spacewill be available, forcorrection and subsequentjoint distraction. The linklocking screws (see arrows)are provisionally tightenedat this point.

Fixator Application

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Following joint reduction, the fixator is mounted onthe lateral side of the humerus and the dorsal aspectof the ulna with the forearm in the neutral position.

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Exposure of the lateralaspect of the humerus ismandatory in order toavoid damage to theradial nerve. A 4-5 cmincision is made, justdistal to the insertion ofthe deltoid, betweentriceps and brachialis.The radial nerve at thislevel, is dorsal to theinsertion sites of thescrews. Care must betaken to avoid damageto the radial nerve andthe neurovascularstructures on the medialaspect of the humerus.

With the triangularknob tightened, thehumeral screws areinserted in the frontalplane, at right angles tothe long axis of thebone. A screw guide isinserted into the mostproximal screw seat ofthe clamp. A 4.8 mmdrill guide is used andthe bone drilled with a4.8 mm drill bit.

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Humeral Screw Insertion

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LATERAL DORSAL

Site ofHumeralScrews

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The drill guide isremoved and a 6/5 mm,100/30 or 110/30cortical screw insertedthrough the screw guide,using the T-wrench. N.B.: If the humerus isless than 20 mm indiameter, the 4.5-3.5mm,100/20 or 120/20screws should be usedafter pre-drilling with the3.2 mm drill bit throughthe 3.2 mm drill guide.

The second humeralscrew is then inserted inthe same fashion, in the4th screw seat of theclamp.

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The screw guides areremoved and the clampcover locking screwstightened. The fixatorshould be positioned ata distance of 15-20 mmfrom the skin to allow forpost-operative swelling.

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Ulnar Screw Insertion

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The ulnar screws areapplied from the dorsalside, again through anopen procedure. Thesescrews are inserted dorsalto the frontal plane, at thesubcutaneous border of theulna, at right angles to thelong axis of the bone, inorder to allow maximumpronation/ supination. It isimportant that the ulnarscrews are placed ascentrally as possible in thetransverse plane in order to avoid weakening thebone. The most distalscrew is inserted first. If thisis not possible with thestraight clamp, an extendedrange clamp should beused (see page 12).

Site ofUlnarScrews

LATERAL1

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A screw guide isinserted into the mostdistal screw seat of theclamp. A 3.2 mm drillguide is used and thebone drilled with a 3.2 mm drill bit.

The drill guide isremoved and a 4.5/3.5 mm, 100/20 or120/20 cortical screwinserted through thescrew guide, using the T-wrench.

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The second ulnarscrew is then inserted inthe same fashion, in the4th screw seat of theclamp.

The screw guides areremoved and the clampcover locking screwstightened.

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An Extended RangeClamp should be useddistally when it isimpossible to align aStraight Clamp with thelong axis of the ulna. TheExtended Range Clampgives the surgeon awider choice of angle ofscrew insertion in theulna.

Fixator alignment isnow checked in the APview; as far as possible,the humeral link shouldbe parallel to the longaxis of the humerus andthe forearm link parallelto the long axis of theulna. The triangular knobshould be tightened atthis point. The ball-jointsare then tightened withthe Allen wrench.

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Final Locking of the Fixator

1/A

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1/B

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With the triangular knobloosened, the elbow isflexed and extended underimage intensification toconfirm correct alignment ofthe device. During thisprocedure, the congruencyof the joint line must be seento be maintained. If there isasymmetric opening of thejoint line, the alignmentbetween the fixator and thebone axes must beconfirmed and the positionof the central connecting unitchecked. Adjustments maybe made by means of thelink locking screws and theball-joints, until correctalignment is obtained. Eachof the link locking screws isnow tightened fully. Finallocking of the ball-joints isperformed using the torquewrench to ensure fixatorstability. The torque wrenchshould ONLY be used totighten the ball-joints. Thefixator is locked at anappropriate angle by meansof the triangular knob of thecentral connecting unit (70° of flexion from fullextension is recommended).The 2 mm Kirschner wire is removed.

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2/A

2/B

2/C

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In cases where it isnecessary to restore jointcongruity using internalfixation (e.g. the OrthofixFragment Fixation System),this is performed followinghumeral and ulnar screwplacement. For joint stability,reconstruction of the radialhead is of paramountimportance. Repair of theligaments is at the discretionof the surgeon. Large bonyligament avulsions may bereattached using theOrthofix Fragment FixationSystem implants togetherwith washers. Leaving theclamps in place on the bonescrews, the remainder of thefixator assembly istemporarily removed, thejoint reconstructed and the 2 mm Kirschner wireinserted through the centre ofrotation of the elbow joint.The fixator assembly is thenreapplied and aligned.

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Whenever possible, the elbow joint is placed in maximal extension.

FORCED MANIPULATION OF THE ELBOW JOINTMUST NOT BE PERFORMED.

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Post-Traumatic Stiffness

When applying thefixator in a case of post-traumatic stiffness, the2 mm Kirschner wireshould be inserted at theproximal border of thering structure in the lateralX-ray (see figure opposite).This is because distractionalong the humeral link willshift the center of rotationdistally and this must becompensated for.

Following fixatorapplication, the elbow jointis distracted to unload thecartilage. Initial distractionmust be performed duringsurgery and a joint widthtwo or three times normalshould be aimed for at thisstage.Small distractors areplaced on both links andtheir locking screws firmlytightened. Whenpositioning the distractors,care should be taken toensure that an adequatelength of distraction screwwill be available.

The main distraction is performed on the humeral link with its locking screw andthe triangular knob loosened. Total distraction is approximately 10 mm. The linklocking screw is then tightened. The small distractor on the ulnar link will be usedto achieve approximately 5 mm of distraction with its locking screw and thetriangular knob loosened. The ulnar link locking screw is tightened at the end ofdistraction. Widening of the joint should be monitored radiographically.

Additional surgery may be required to clean the olecranon fossa or the anteriorjoint compartment, or to remove heterotopic bone bridges. The ulnar nerve mayrequire decompression and occasionally anterior transposition.

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Distraction alongthe Humeral Link

H

Center

K-Wire

U

CP

Symmetric Distraction

Distraction alongthe Ulnar Link

O = OlecranonCP = Coronoid Process

H = HumerusU = Ulna

CP CP

CP

CP

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Long-Standing StiffnessIn cases of long-standing stiffness of the elbow, use of the small distractors will notbe sufficient to widen the joint space. After insertion of the humeral and ulnarscrews for the elbow fixator, the central body is removed. A short or standardOrthofix fixator body with a T-clamp distally is now applied to the proximal(humeral) clamp. Two 3.5/4.5 mm screws are inserted through the T-clamp intothe olecranon. Distraction is performed using the standard compression-distractionunits. The joint should be distracted until it is two to three times normal. Afterrelaxation of the soft tissues intra-operatively (approx. 15-20 min.) the standard orshort fixator is removed and the elbow fixator applied. Re-distraction is nowperformed using the small distractors on the humeral and ulnar links.

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Patients are encouraged to pronate and supinate theforearm from day 1 post-operatively. Flexion andextension of the elbow should be commenced aftersoft tissue healing on day 4 and under the supervisionof a physiotherapist. Flexion and extension of theelbow is obtained by unlocking the central triangularknob. Where there are no contraindications to its use,patients may receive indomethacin 50 mg twice dailyfor 4 weeks following operation, in order to preventheterotopic bone formation. Lateral X-rays are takenusing a dental film inserted between skin and fixator.

Post-Operative ManagementAcute Trauma

If, following operation, the joint space is less thantwice its normal width, subsequent post-operativedistraction is performed on the humeral link at anaverage rate of 2 mm per day in four steps of0.5 mm (one full turn of the distractor screw equals1 mm). Clinical experience has shown that a jointspace twice the normal width should be aimed for tounload the articular cartilage. Distraction ismaintained throughout the treatment period andwidening of the joint monitored using standardradiographs. Patients are encouraged to pronate and supinate theforearm from day 1 post-operatively. Flexion and extension of the elbow should be commencedfour days after the completion of distraction byunlocking the triangular knob.A functional range of movement greater than 100°is considered necessary for adequate upper limbfunction. It is, however, more important to gain fullflexion than full extension.

Post-Traumatic Stiffness

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The standard compression-distraction unit,inserted into the cams of the fixator, may beused together with physiotherapy to increaseflexion of the elbow joint, by turning the compression-distraction screw clockwise, at arate of 1-4 mm per day (compression mode).

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Alternatively, the long compression-distractionunit together with its spacers may be used toextend the fixator fully, by turning thecompression-distraction screw anticlockwise(distraction mode).

The compression-distraction units may beremoved intermittently for active and passivephysiotherapy and/or for the use of a ContinuousPassive Motion device. Too vigorous a use ofmechanical distraction or compression is notrecommended, since this may stretch the ulnarnerve and cause temporary or permanentdamage.

Where there are no contraindications to its use,patients may receive indomethacin 50 mg twicedaily for 4 weeks following operation, in orderto prevent heterotopic bone formation.

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Pin Site CareThe visible parts of the screws and surroundingskin should be cleaned on the day followingapplication of the fixator and at least once aday thereafter. Only sterile water should be usedfor this purpose. A dry absorbent dressing withadditional gauze is used around the pin sites.Circular bandages should be avoided. After afew days, when the pin sites are dry, nodressing is needed. Some serous fluid may leak from the pin sites asa result of excessive elbow mobility andsubsequent irritation of the tissues around thescrews. Normal care on pin cleaning is required.Where inflammation is seen and the exudate ispurulent, with the skin around the screw red andwarm, a bacteriological swab should be takenand the appropriate antibiotic given for about aweek. Motion should be restricted until resolutionhas occurred. Please refer to the Orthofix video entitled “Pin Site Care” for additional information.

Fixator RemovalIn acute cases, this will normally occur at 4-6weeks following operation, depending upon thesurgeon’s assessment, and at 4 weeks in post-traumatic cases. If there is any doubt as towhether healing is complete, the device may beremoved provisionally at this time, leaving thebone screws in situ for a few days, to enable thefixator to be replaced for a further week, if thereis evidence of persisting pain or instability. Atthe end of this period, a further attempt toremove the fixator should be made.

X-raysX-rays should be taken immediately post-operatively and every 2 weeks thereafter,throughout the healing period, to assessprogress. To obtain a true lateral X-ray, a dentalfilm may be inserted between the skin and thefixator body.

Bibliography

1. Breen T.F., Gelbermann R.H., Ackermann G.N. Elbow flexion contractures:treatment by anterior release and continuous passive motion. Journal of HandSurgery, 1988; 13: 286-287.

2. Bryan R.S., Bickel W.H. T-condylar fractures of the distal humerus. Journal ofTrauma, 1971; 11: 830-835.

3. Gausepohl T., Pennig D., Mader K. Der transartikuläre Bewegungsfixateurbei Luxationen und Luxationsfrakturen des Ellenbogengelenkes. OsteosyntheseInternational, 1997; 5: 102-110.

4. Gausepohl T., Pennig D. Luxationen und Luxationsfrakturen des Ellenbogens -Einsatz des Bewegungsfixateurs. In: Ellenbogenchirurgie in der Praxis (Eds.: R.P.Meyer, U. Kappeler), Springer-Verlag, Berlin-Heidelberg-New York (1988): 161-182.

5. Green D.P., McCoy H. Turnbuckle orthotic correction of elbow-flexion. Journal ofBone and Joint Surgery [Am], 1979; 61: 1092-1095.

6. Husband J.B., Hastings H. The lateral approach for operative release of post-traumatic contracture of the elbow. Journal of Bone and Joint Surgery [Am], 1990;72: 1353-1358.

7. Josefsson P.O., Johnell O., Gentz C.F. Long-term sequelae of simpledislocations of the elbow. Journal of Bone and Joint Surgery [Am], 1984; 66: 927-930.

8. Morrey B.J. Post-traumatic contracture of the elbow. Journal of Bone and JointSurgery [Am], 1990; 72: 601-618.

9. Morrey B.J., Adams R., Bryan R.S. Total replacement for post-traumaticarthritis of the elbow. Journal of Bone and Joint Surgery [Br], 1991; 73: 607-612.

10. Morrey B.J. (ed.). The elbow and its disorders, 2nd edn. Saunders,Philadelphia-London-Toronto, Chapter 29.

11. Pennig D., Gausepohl T. Die posttraumatische Ellenbogensteife -Gelenkdistraktion mit Fixateur externe als Behandlungskonzept. In:Ellenbogenchirurgie in der Praxis (Eds.: R.P. Meyer, U. Kappeler), Springer-Verlag,Berlin-Heidelberg-New York (1998): 183-205.

12. Shattacharyya S. Arthrolysis: A new approach to surgery of post-traumatic stiffelbow. Journal of Bone and Joint Surgery [Br], 1974; 56: 567.

13. Thompson H.C., Garcia A. Myositis ossificans: Aftermath of elbow injuries.Clinical Orthopedics, 1967; 50: 129-134.

14. Urbaniak J.R., Hansen P.E., Beissinger S.F., Aitken M.S. Correction ofpost-traumatic flexion contracture of the elbow by anterior capsulotomy. Journal ofBone and Joint Surgery [Am], 1985; 67: 1160.

15. Volkov M.F., Oganesian O.V. Restoration of function in the knee and elbowwith a hinge distractor apparatus. Journal of Bone and Joint Surgery [Am], 1975;57: 591-600.

16. Willner P. Anterior capsulectomy for contractures of the elbow. Journal of Int.Coll. Surgery, 1948; 11: 359.

17. Weizenbluth M., Eichblat M., Lipskeir E., Kessler I. Arthrolysis of theelbow: 13 cases of post-traumatic stiffness. Acta Orthopaedia Scandinavia, 1989;60: 642.

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SterilizationWhen products are used for the first time, theyshould be removed from their containers andproperly cleaned using medical grade alcohol70% + distilled water 30%. After cleaning, thedevices should be rinsed with sterile distilledwater and dried using clean non-woven fabric.Prior to surgical use, the products should becleaned as described above and sterilized bysteam autoclaving following a validatedsterilization procedure, utilizing a prevacuumcycle (Orthofix recommends the following cycle:steam autoclave 132°-135°C (270°-275°F),minimum holding time 10 minutes).The fixator can be sterilized in the assembledstate as long as ball-joints, central connectingunit and clamp locking screws are leftuntightened.Note that bone screws are for single use onlyand must not be re-used.

The Orthofix Quality System has been certified tobe in compliance with the requirements of: ■ Medical Devices Directive 93/42/EEC,

Annex II - (Full Quality System) ■ International Standards EN 46001/ISO 9001for orthopaedic external fixator systems including bone screws, nails and wires, sterileexternal and internal fixation systems.

The Orthofix Elbow Fixator

■ Minimally invasive and rapidly applied■ Controlled movement about the axis of

rotation of the elbow joint■ Immediate pronation and supination, and

early flexion and extension■ Facility for gradual extension or flexion where

required■ Well tolerated by the patient

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Reduction afterpostero-medialdislocation of theelbow in a 32year old patient. Note: Alignment ofthe fixator axiswith humerus andulna. Axis ofrotation of fixatorin correct position.

Extension/flexion at nine weeks.

AP and lateral films takenfive weeks after fixatorapplication showingcongruency of the joint and no heterotopic boneformation.

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Full extension and full flexion at five weeks, prior tofixator removal.2

Fracture-dislocation of theelbow involving the radialhead and coronoid process in a 46 year old woman.

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Pronation/supination at nine weeks.4

Case 2

Clinical CasesAcute Trauma

Case 1

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Extension/flexion at two weeks.

Post-Traumatic Stiffness

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Intra-operative distraction with widening of the joint line.

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The Orthofix Elbow Fixatorwas developed in collaboration

with Prof. Dr. D. Pennig,St Vinzenz-Hospital, Köln, Germany

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Restriction offlexion/extension to a totalof 40° in a 32 year oldfemale after a posteriordislocation of the elbow.Note: Extremely narrow jointline and disuse osteoporosis.

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Extension/flexion at nine weeks.4 AP film of the joint at six months showing normal joint width and someresidual osteoporosis.

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Case 1

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Ordering Information

STERILIZATION BOX EMPTY 12.270Can accommodate:QTY CODE N° DESCRIPTION1 10.074 Elbow Fixator Central Body

complete with Small Distractor, two Cams and two Bushes2 90.006 Straight Clamp 1 90.090 Elbow Extended Range Clamp1 10.008 Compression-distraction Unit Standard (extends to 4 cm)1 10.009 Compression-distraction Unit Long (extends to 8 cm)1 10.076 Spacers for Compression-distraction Unit (1 pair)

2 11.001 Drill Bit Kit Ø 4.8 mm, each consisting of:1 11.001A Drill Bit, length 180 mm Ø 4.8 mm1 11.005 Stop Unit Ø 4.8 mm1 10.012 Allen Wrench 3 mm

2 13.003 Drill Bit Kit Ø 3.2 mm, each consisting of:1 13.003A Drill Bit, length 140 mm Ø 3.2 mm1 11.006 Stop Unit Ø 3.2 mm1 10.012 Allen Wrench 3 mm

4 11.102 Screw Guide, length 60 mm2 11.104 Drill Guide, length 40 mm Ø 4.8 mm2 11.106 Drill Guide, length 40 mm Ø 3.2 mm1 10.025 Torque Wrench1 11.004 Tapered Trocar1 10.017 Polyhedral Allen Wrench 6 mm1 11.000 T-Wrench4 11.146 Kirschner Wire, length 150 mm Ø 2mm4 10.137 Cortical screw 6 mm shaft diameter,

120/20 x 4.5 - 3.5 mm thread diameteror

4 10.135 Cortical screw 6 mm shaft diameter,100/20 x 4.5 - 3.5 mm thread diameter

4 10.110 Cortical screw 6 mm shaft diameter,110/30 x 6 - 5 mm thread diameteror

4 10.162 Cortical screw 6 mm shaft diameter,100/30 x 6 - 5 mm thread diameter

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QTY CODE N° DESCRIPTION1 10.071 Elbow Fixator Central Connecting Unit1 10.072 Small Distractor 1 10.073 Link Locking Screw 1 M135 Plate Locking Screw 1 10.004 Cam 1 90.005 Bush

REPLACEMENT COMPONENTS

Notes

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