Marathon and Enduron Polyethylene at Long-Term Follow-up
NCT ID: NCT02508428
Last Updated: 2020-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
1999-01-06
2017-06-22
Brief Summary
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Detailed Description
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While crosslinking has proven to substantially reduce polyethylene wear during the first decade in vivo, characterizing the long-term clinical performance of Marathon polyethylene remains important because crosslinking is accompanied by a reduction in the ultimate tensile strength, fatigue strength, and elongation to failure of ultra high molecular weight polyethylene. As a consequence, concerns have been expressed about the potential for the liner fracture, in vivo polyethylene oxidation or accelerated wear at long-term follow-up, the effects of femoral head roughening over time and the bioreactivity of crosslinked polyethylene debris particles. Ultimately, the best way to address these concerns is in the context of well-controlled, long-term clinical outcome studies. This study will evaluate outcome at a minimum of 14-years after surgery among the same group of patients whose outcome was previously reported at 10-year follow-up. As part of our efforts to follow patients throughout their lives to obtain long-term outcome data, we will continue to obtain routine follow-up every 5 years from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years). Because we anticipate that the reduced incidence of wear and osteolysis will result in a lower incidence of revision surgery among the patients randomized to Marathon liners, implant revision for reasons related to wear will be our primary outcome measure at long-term follow-up.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Crosslinked Marathon polyethylene
The crosslinked Marathon polyethylene liners used for the primary total hip replacements in this study were treated with 5 Mrad (50 kGy) of gamma irradiation to induce crosslinking and then heated above the melting temperature (150 degrees Celsius) to eliminate free radicals. This manufacturing process was designed to improve the polyethylene's resistance to wear through increased crosslinking and eliminate free radicals that render it susceptible to oxidative degradation. These liners were machined and terminally sterilized with gas plasma, a noncrosslinking chemical surface treatment. These liners did not have had free radicals at the time of implantation and did not incorporate antioxidants.
Hip Replacement with crosslinked Marathon polyethylene
Comparison of Marathon and Enduron polyethylene
Noncrosslinked Enduron polyethylene
The standard, noncrosslinked Enduron polyethylene liners used for the primary total hip replacements in this study were manufactured from the same polyethylene resin as the crosslinked Marathon liners but never irradiated. Like the Marathon components, these liners were machined and terminally sterilized with gas plasma, a noncrosslinking chemical surface treatment. Based on the manufacturing methods, these liners would not have had free radicals at the time of implantation and did not incorporate antioxidants.
Hip Replacement with noncrosslinked Enduron polyethylene
Interventions
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Hip Replacement with crosslinked Marathon polyethylene
Comparison of Marathon and Enduron polyethylene
Hip Replacement with noncrosslinked Enduron polyethylene
Eligibility Criteria
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Inclusion Criteria
* Elective total hip replacement patient
(from 10-year follow-up)
* Consented to the original study.
* Received a Duraloc 100 cup with either a crosslinked Marathon or standard Enduron liner.
* Received an AML/Solution or a Prodigy stem with 28mm cobalt chrome femoral head.
* Patient refused to consent to continued follow-up.
Exclusion Criteria
* None
(from 10-year follow-up)
ALL
Yes
Sponsors
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DePuy Orthopaedics
INDUSTRY
Anderson Orthopaedic Research Institute
OTHER
Responsible Party
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Principal Investigators
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C. Anderson Engh, Jr., MD
Role: PRINCIPAL_INVESTIGATOR
Anderson Orthopaedic Research Institute
Locations
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Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States
Countries
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References
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Leung SB, Egawa H, Stepniewski A, Beykirch S, Engh CA Jr, Engh CA Sr. Incidence and volume of pelvic osteolysis at early follow-up with highly cross-linked and noncross-linked polyethylene. J Arthroplasty. 2007 Sep;22(6 Suppl 2):134-9. doi: 10.1016/j.arth.2007.04.006. Epub 2007 Jul 27.
Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006 Sep;21(6 Suppl 2):17-25. doi: 10.1016/j.arth.2006.05.002.
Engh CA Jr, Hopper RH Jr, Huynh C, Ho H, Sritulanondha S, Engh CA Sr. A prospective, randomized study of cross-linked and non-cross-linked polyethylene for total hip arthroplasty at 10-year follow-up. J Arthroplasty. 2012 Sep;27(8 Suppl):2-7.e1. doi: 10.1016/j.arth.2012.03.048. Epub 2012 Jun 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AORI2015-0100
Identifier Type: -
Identifier Source: org_study_id