Design Rationale - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...

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Design Rationale

Transcript of Design Rationale - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...

Page 1: Design Rationale - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North Americ… · Traditionally, most THAs have been performed through the posterior or

Design Rationale

Page 2: Design Rationale - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North Americ… · Traditionally, most THAs have been performed through the posterior or
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Approach Patients with C O N F I D E N C E

The ACTIS® Total Hip System is the first

DePuy Synthes stem specifically designed to be utilized

with tissue sparing approaches, such as the anterior

approach, as well as traditional approaches. The implant

and instrumentation are designed to balance ease-of-

insertion and may provide improved implant stability.1

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A Triple Aim Solution

VALUE

IMPR

OV

ED

OU

TCO

MES

PATIEN

T

SATISFA

CTION

From potential for improved outcomes to better patient

satisfaction to greater value, the ACTIS Total Hip System

can help you achieve your surgery center’s Triple Aim goals.

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A Triple Aim Solution

Patient Satisfaction Driven by a Surgical Technique That May Enable Early Patient Function3

Although the ACTIS Hip System is compatible with patient positioning in many of the popularized surgical approaches, it was developed to be conducive to tissue sparing approaches such as the Anterior Approach.

Improved Outcomes Supported by Enhanced Initial Implant Stability1,2

The ACTIS Hip System has features, such as a medial collar and triple taper geometry, that have been shown to improve primary stability of the stem versus a non-collared stem.

Value Created by One System to Serve More Patients

The ACTIS Hip System was designed to reduce the variety of hip stems needed to serve an increasingly diverse patient population while providing efficiencies that help streamline the surgical process.

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Full HA coating

The ACTIS Hip System has features, such as a medial collar and triple taper

geometry, that have been shown to improve primary stability of the stem

while also offering a solution for a broader range of patient anatomies.

Improved Outcomes Supported by Enhanced Initial Implant Stability1,2

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Medial collar

Variable triple-tapered geometry

Proximal DUOFIX® Coating

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Medial Collar

Features That Enhance Implant Stability

May reduce likelihood of femur fracture

The amount of force necessary to cause a femur fracture was higher for the ACTIS Stem than that of a biomechanically similar test device without a collar in the study, which suggests the ACTIS Stem may reduce the occurrence of femur fractures in patients.4

Reduced potential for rotation and subsidence

The natural loading of the femur with a medial collar provides greater primary stability for immediate weight bearing within days of surgery, and reduces potential of subsidence.1 Subsidence has been shown to lead to other complications such as dislocation of the Hip joint.4

Fit-and-Fill StemVariable triple-tapered geometry

The ACTIS Stem is tapered in three separate planes to aid in the short and long-term stability of the stem. It is tapered from proximal to distal in the anterior-posterior plane, proximal to distal in the medial lateral plane and lateral to medial in the transverse or axial plane.

The ACTIS Stem was designed to grow 1mm in the anterior-posterior thickness in the horizontal plane consistently between each size stem. Additionally, the ACTIS System Anterior-Posterior Taper grows 1/4 degree per size to ensure a proper fit into the canal with the larger stem sizes.

Horizontal plane grows 1mm in the A/P per size

ACTIS Collared Stem

Ave

rag

e R

ota

tio

n (

Deg

)

Stem Rotation Stem Subsidence Failure Load

Collarless Triple Taper Stem SUMMIT® Hip System

Ave

rag

e Su

bsi

den

ce (

mm

)

Failu

re L

oad

(N

)

0.0

0.5

1.0

1.5

2.0

2.5

0.0

0.5

1.0

1.5

2.0

2.5

0

875

1750

2625

3500

4375

5250

6125

7000

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DUOFIX HA Coating combines POROCOAT Porous Coating, which allows for biological fixation to bone, with the addition of a 35 micron layer of HA coating.5

4 weeks 8 weeks 12 weeks

Featuring DUOFIX® Hydroxyapatite (HA) Coating

DUOFIX HA Coating is present on the proximal portion of the ACTIS Stem, including the underside of the collar.

• POROCOAT® Porous Coating (pictured below) has been on the market since 1977 and has over 30 years of clinical heritage.

• HA is a highly crystalline form of calcium phosphate, which is one of the mineral components of bone.

• 35 micron non-occluding plasma spray deposited HA coating.

ACTIS Hybrid Broaches feature compaction broach pattern on the anterior/posterior sides and extraction teeth on the medial/lateral sides of the broach.

Combining extraction and compaction broaching technology allows for preservation of patient anatomy while ensuring adequate fit in the canal.

Bone Preserving Philosophy

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Patient Satisfaction Driven by a Surgical Technique That May Enable Early Patient Function3

The ACTIS Hip System combines design

features and biomechanics to deliver a

total hip system that provides ease of use

and stability to optimize a surgeon’s

preferred surgical approach. The ACTIS

Hip System was designed to be conducive

to tissue sparing approaches such as the

Anterior Approach.

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Traditionally, most THAs have been performed through the posterior or lateral approach. Even in “minimally-invasive” small-incision variations, these approaches require significant cutting and sectioning of both muscle and ligaments. In contrast, the Anterior Approach does not section any muscle or ligament, or release them from the bone. This increases stability of the joint immediately after surgery, decreasing dislocation rates that may be seen with the other surgical approaches. It may also prevent the limp caused by releasing the gluteal muscles in the lateral approach. The size of the incision has less impact on the outcome than the damage done to the soft tissue.6

Reduced Readmission Rate Due to Dislocations

Anterior Approach May Offer an Early Return to Function

DISLOCATION RATE7

Anterior Approach

Anterolateral Approach

Posterior Approach

1%

2%

4%

Studies suggest potential for more rapid recovery of overall hip function with the Anterior Approach.9,10

Low incidence of dislocation after primary THA in absence of early postoperative restrictions.8

Reduced Length of Hospital Stay

Anterior Approach may offer reduced hospital stays relative to popular surgical approaches.3

Anterior Approach

2.28 DAYS

3.02 DAYS

Posterior Approach

POST-OPERATIVE SUMMARY STATISTICS AT SIX WEEKS

(P<0.0001 FOR EACH MEASURE)

Anterior Approach Scores

Traditional Anterolateral Scores

100

90

80

70

60

50

40

30

20

10

0Harris Hip

ScoreHarris HipPain Score

>6 Blocks

(%)

Stairs No Banister

(%)

Socks/Shoes(%)

Full Activity

(%)

Outcome Measure

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Anterior Approach Enabling Features of the ACTIS Hip System

Reduced Lateral ShoulderTo enable tissue-sparing approaches, such as the Anterior Approach, the ACTIS Stem was designed with a reduced lateral shoulder to aid in stem insertion by helping avoid the Obturator Externus muscle and other short external rotators that attach to the medial aspect of the greater trochanter.

Appropriate LengthThe ACTIS Stem comes in 12 sizes ranging from size 1 to size 12 with both standard and high offset. Consistent with other DePuy Synthes Companies broach-only systems, the ACTIS System offers sizes (from 97mm–119mm stem lengths) to accommodate a larger range of patient anatomies.11

Size Range97mm–119mm

Size 1 97mm

Size 12 119mm

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Angled Insertion Feature For Improved AccessThe ACTIS Stem was designed with a new patented 12 degree insertion feature (as shown) to facilitate easier instrument access around soft tissue and bony structures encountered with the Anterior Approach, for example.

Neck Resection Guide Designed For Use With FluoroscopyThe ACTIS Hip System also offers a new neck resection guide that can be used with fluoroscopy to more accurately establish the angle of resection at a proper 50 degrees from the femoral axis.

12° Insertion Feature

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Value Created by One System to Serve More Patients

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Improved Anatomical Fit The ACTIS Hip System will enable access to more patients with unique design features and instrumentation that help ensure a precise fit.

Extended Size RangeThe ACTIS Stem features 12 sizes, allowing the surgeon to address a wide range of patients. Consistent intervals between each stem size help achieve proper fit within the femur. Component sizing can also be used to fine tune seating height and adjust leg length.

Progressive Dual OffsetStem offset is proportional to stem size. Each stem size offers a standard and high offset option. The high offset option lateralizes the stem 6–8 mm depending on size. By maintaining a constant 130˚ neck angle, tissue tension can be increased without affecting leg length.

Reduced Distal ThicknessWith a reduced distal tip of the stem, the ACTIS Hip System will enable bone preservation and work well with various femoral morphologies. The triple taper proximal geometry is meant to provide adequate support so that more distal cancellous bone can be preserved.

The ACTIS Hip System was designed to reduce the variety of hip stems

needed to serve a broader patient population while providing efficiencies

that streamline the surgical process and reduce OR footprint.

One System to Serve More Patients*

*Compared to SUMMIT DUOFIX Hip Stem

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References

1. Hamburg University Actis Cadaveric Stability Testing. Data on File (Adaptiv #103156243).

2. Demey, G., Fary, C., Lustig, S., et. al. “Does a Collar Improve the Immediate Stability of Uncemented Femoral Hip Stems in Total Hip Arthroplasty? A Bilateral Comparative Cadaver Study.” JOA, 2011 26(8), pp.1549-1555.

3. Barrett, W., et al. “Prospective Randomized Study of Direct Anterior vs Postero-Lateral Approach for Total Hip Arthroplasty. JOA, 2013 28, pp 1634-1638.

4. Pentlow AK, Heal JS. “Subsidence of collarless uncemented femoral stems in total hips replacements performed for trauma.” Injury, 2012 43(6), pp. 882-885

5. Pilliar RM. Powder metal-made orthopaedic implants with porous surface for fixation by tissue ingrowth Clin Orthop 1983:150.

6. Blasser KE. “Advances in Total Hip Replacement: Minimally Invasive Surgery.” Northeast Florida Medicine. 2006;57:21-23.

7. Horne, PH., Olson, S. “Direct Anterior Approach for Total Hip Arthroplasty using the Fracture Table” Curr Rev Musculoskelet Med (2011) 4:139-145.

8. Restrepo c, Mortazi J, Brothers J, Parvizi J, Rothman R: Hip Dislocations: Are Hip Precautions Necessary in Anterior Approaches? Clin Orthop Related Research. Hip Society Meetings Symposium Paper, 2010.

9. St Mark’s Hospital Case Study (Salt Lake City, UT) “Anterior Approach Hip Replacement Surgery Yields Increased Volume and Reduced Resource Utilization”

10. Bhandari: Outcomes following the single incision Anterior Approach to THA: A multi-center observational study. Orthop Clin North Am, 40(3):329-342, 2009.

11. See Surgical Technique for sizing information.

© DePuy Synthes 2016. All rights reserved. DSUS/JRC/1215/1188(2) 10/16

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