Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis
NCT ID: NCT04019925
Last Updated: 2019-07-15
Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2019-09-01
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADM/MDM hip prosthesis
Type of prosthesis participant received.
ADM/MDM hip
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* BMI that is 19 or less
* BMI that is greater than 36
* Most recent x-rays less than 3 years postop
18 Years
75 Years
ALL
Yes
Sponsors
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Stryker Orthopaedics
INDUSTRY
Unity Health Toronto
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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19-061
Identifier Type: -
Identifier Source: org_study_id
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