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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Assessing the Wear Rates of the ADM/MDM Dual Mobility Hips Manufactured by Stryker Orthopaedics Using 3D X-ray Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04019925
• Other study ID #: 19-061
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: July 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Kerry Ann K. Griffith-Cunningham
• Phone: 416 864-6060
• Email: griffithk[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 31, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

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

Locations

Country	Name	City	State
Canada	Unity Health Toronto, St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Stryker Orthopaedics

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Barrack RL. Dislocation after total hip arthroplasty: implant design and orientation. J Am Acad Orthop Surg. 2003 Mar-Apr;11(2):89-99. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Bone Joint J. 2017 May;99-B(5):702-704. — View Citation

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. — View Citation

Hailer NP, Weiss RJ, Stark A, Kärrholm 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Kostensalo I, Junnila M, Virolainen P, Remes V, Matilainen M, Vahlberg T, Pulkkinen P, Eskelinen A, Mäkelä 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To review the number of postop hip dislocations/hip instabilities	Dislocations and the post op time for each occurrence per patient will be collected in tabular format. This in turn will be used to calculate percent of cases/subject.	first 5 years post surgery

External Links

•   Canadian Joint Replacement Registry Annual Report. Hip & Knee Replacements in Canada 2016-2017.