NCT04019925

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 3, 2019

Last Update Submit

July 12, 2019

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

  • To assess the change in polyethylene wear of Dual Mobility hip implants using Stryker Orthopaedics ADM & MDM prostheses

    This study will assess the change in linear and volumetric wear using 3D x-ray analysis. Measurements will be taken of x-rays obtained before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken more than 3 years postop.

    before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken up to 5 years postop.

Secondary Outcomes (1)

  • To review the number of postop hip dislocations/hip instabilities

    first 5 years post surgery

Study Arms (1)

ADM/MDM hip prosthesis

OTHER

Type of prosthesis participant received.

Device: ADM/MDM hip

Interventions

ADM/MDM hipDEVICE

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

Also known as: Dual Mobility Hip
ADM/MDM hip prosthesis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female
  • Skeletally mature
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (12)

  • 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.

    PMID: 19797590BACKGROUND

  • 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.

    PMID: 12670135BACKGROUND

  • 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.

    PMID: 16741469BACKGROUND

  • 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.

    PMID: 25573179BACKGROUND

  • 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.

    PMID: 23039167BACKGROUND

  • 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.

    PMID: 23799348BACKGROUND

  • 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.

    PMID: 18521598BACKGROUND

  • 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.

    PMID: 29305445BACKGROUND

  • 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.

    PMID: 28042114BACKGROUND

  • 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.

    PMID: 29307678BACKGROUND

  • 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.

    PMID: 23434106BACKGROUND

  • 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.

    PMID: 26897488BACKGROUND

Study Officials

  • Amit Atrey, MD

    Unity Health Toronto, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry Ann K. Griffith-Cunningham

CONTACT

416 864-6060griffithk@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 15, 2019

Study Start

September 1, 2019

Primary Completion

March 30, 2020

Study Completion

August 31, 2020

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)