Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis

NCT ID: NCT04019925

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-08-31

Brief Summary

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A common complication post hip replacement is hip dislocation or hip instability which can lead to the hip implants being revised. A new generation of Dual Mobility hips was designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing 2 dual mobility hips manufactured by Stryker Orthopaedics Inc. The ADM and the MDM.

Detailed Description

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Hip replacement is a procedure in which the hip joint is replaced by a prosthetic implant or prosthesis. Post op hip dislocation or hip instability is a common complication which can lead to the hip implants being revised. There are many types of hip prostheses manufactured with the aim of prolonging longevity of the prosthesis and minimizing postoperative complications. One of these is a new generation of dual mobility hip manufactured by Stryker Orthopaedics. The Anatomic Dual Mobility (ADM) and the Modular Dual Mobility (MDM) were designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing the outcome of the ADM and MDM hip system.

Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADM/MDM hip prosthesis

Type of prosthesis participant received.

Group Type OTHER

ADM/MDM hip

Intervention Type DEVICE

Dual Mobility Hip prosthesis manufactured by Stryker Orthopaedics: ADM/MDM

Interventions

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ADM/MDM hip

Dual Mobility Hip prosthesis manufactured by Stryker Orthopaedics: ADM/MDM

Intervention Type DEVICE

Other Intervention Names

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Dual Mobility Hip

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant female
* Skeletally mature
* 18 to 75 years old
* Stryker Dual Mobility Hip prosthesis
* BMI between 20 and 35
* Follow-up x-rays between 3 years and 6 years postop

Exclusion Criteria

* Dual Mobility Hip implant that is not the ADM or MDM
* BMI that is 19 or less
* BMI that is greater than 36
* Most recent x-rays less than 3 years postop
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stryker Orthopaedics

INDUSTRY

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit Atrey, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto, St. Michael's Hospital

Locations

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Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Kerry Ann K. Griffith-Cunningham

Role: CONTACT

416 864-6060 ext. 2273

References

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Huo MH, Parvizi J, Bal BS, Mont MA. What's new in total hip arthroplasty. J Bone Joint Surg Am. 2009 Oct;91(10):2522-34. doi: 10.2106/JBJS.I.00801. No abstract available.

Reference Type BACKGROUND
PMID: 19797590 (View on PubMed)

Barrack RL. Dislocation after total hip arthroplasty: implant design and orientation. J Am Acad Orthop Surg. 2003 Mar-Apr;11(2):89-99. doi: 10.5435/00124635-200303000-00003.

Reference Type BACKGROUND
PMID: 12670135 (View on PubMed)

Khatod M, Barber T, Paxton E, Namba R, Fithian D. An analysis of the risk of hip dislocation with a contemporary total joint registry. Clin Orthop Relat Res. 2006 Jun;447:19-23. doi: 10.1097/01.blo.0000218752.22613.78.

Reference Type BACKGROUND
PMID: 16741469 (View on PubMed)

Goel A, Lau EC, Ong KL, Berry DJ, Malkani AL. Dislocation rates following primary total hip arthroplasty have plateaued in the Medicare population. J Arthroplasty. 2015 May;30(5):743-6. doi: 10.1016/j.arth.2014.11.012. Epub 2014 Nov 26.

Reference Type BACKGROUND
PMID: 25573179 (View on PubMed)

Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8.

Reference Type BACKGROUND
PMID: 23039167 (View on PubMed)

Kostensalo I, Junnila M, Virolainen P, Remes V, Matilainen M, Vahlberg T, Pulkkinen P, Eskelinen A, Makela KT. Effect of femoral head size on risk of revision for dislocation after total hip arthroplasty: a population-based analysis of 42,379 primary procedures from the Finnish Arthroplasty Register. Acta Orthop. 2013 Aug;84(4):342-7. doi: 10.3109/17453674.2013.810518. Epub 2013 Jun 25.

Reference Type BACKGROUND
PMID: 23799348 (View on PubMed)

Philippot R, Camilleri JP, Boyer B, Adam P, Farizon F. The use of a dual-articulation acetabular cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 15 years. Int Orthop. 2009 Aug;33(4):927-32. doi: 10.1007/s00264-008-0589-9. Epub 2008 Jun 3.

Reference Type BACKGROUND
PMID: 18521598 (View on PubMed)

Darrith B, Courtney PM, Della Valle CJ. Outcomes of dual mobility components in total hip arthroplasty: a systematic review of the literature. Bone Joint J. 2018 Jan;100-B(1):11-19. doi: 10.1302/0301-620X.100B1.BJJ-2017-0462.R1.

Reference Type BACKGROUND
PMID: 29305445 (View on PubMed)

De Martino I, D'Apolito R, Soranoglou VG, Poultsides LA, Sculco PK, Sculco TP. Dislocation following total hip arthroplasty using dual mobility acetabular components: a systematic review. Bone Joint J. 2017 Jan;99-B(ASuppl1):18-24. doi: 10.1302/0301-620X.99B1.BJJ-2016-0398.R1.

Reference Type BACKGROUND
PMID: 28042114 (View on PubMed)

Harwin SF, Sultan AA, Khlopas A, Chughtai M, Sodhi N, Piuzzi NS, Mont MA. Mid-Term Outcomes of Dual Mobility Acetabular Cups for Revision Total Hip Arthroplasty. J Arthroplasty. 2018 May;33(5):1494-1500. doi: 10.1016/j.arth.2017.12.008. Epub 2017 Dec 14.

Reference Type BACKGROUND
PMID: 29307678 (View on PubMed)

Loving L, Lee RK, Herrera L, Essner AP, Nevelos JE. Wear performance evaluation of a contemporary dual mobility hip bearing using multiple hip simulator testing conditions. J Arthroplasty. 2013 Jun;28(6):1041-6. doi: 10.1016/j.arth.2012.09.011. Epub 2013 Feb 22.

Reference Type BACKGROUND
PMID: 23434106 (View on PubMed)

D'Apuzzo MR, Koch CN, Esposito CI, Elpers ME, Wright TM, Westrich GH. Assessment of Damage on a Dual Mobility Acetabular System. J Arthroplasty. 2016 Aug;31(8):1828-35. doi: 10.1016/j.arth.2016.01.039. Epub 2016 Jan 30.

Reference Type BACKGROUND
PMID: 26897488 (View on PubMed)

Other Identifiers

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19-061

Identifier Type: -

Identifier Source: org_study_id

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