- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01484002
Analysis of Crosslinked and Conventional Polyethylene Explants
Collaborative Analysis of UHMWPE Explants: Conventional UHMWPE With No Radiation and Marathon
Study Overview
Detailed Description
For many years, gamma-irradiation in air was a common method for the terminal sterilization of ultrahigh molecular weight polyethylene (UHMWPE) materials used for joint replacement. A serendipitous byproduct of sterilization with gamma-irradiation was polymer crosslinking that tended to improve the wear performance of the polyethylene. During the 1990s, however, the orthopaedic community became aware that gamma-irradiation created free radicals within polyethylene, rendering the material susceptible to oxidative degradation. In view of this potentially deleterious effect, terminal sterilization methods using chemical surface treatments were developed to avoid free radical formation. To induce polyethylene crosslinking without residual free radicals, manufacturers also developed methods to crosslink the polyethylene followed by heat treatments to eliminate free radicals. These crosslinked materials were introduce during the latter part of the 1990s and clinical outcome studies among hip replacement patients have demonstrated substantially reduced wear at early follow-up intervals based on radiographic measurements. However, the long-term performance of crosslinked polyethylene is unknown and some investigators have expressed concerns related to in vivo degradation. Additionally, some crosslinked UHMWPE components have shown high levels of oxidation and chain scission after removal from patients and storage in air. Among these implants, it is unknown whether the oxidation and chain scission occurred during implantation or after the polyethylene was removed from the patient.
This study will characterize the material properties of polyethylene liners retrieved from hip replacement patients. The study population will include crosslinked and conventional UHMWPE liners that were terminally sterilized without the use of radiation. To quantify the potential effects of different storage methods, liners that were vacuum packed and frozen after retrieval and others that were stored at room temperature with access to ambient light and air following explantation will be included in the study population. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink density measurements will be evaluated as a function of distance away from the articular surface and the rim of the implant. Gel and hydroperoxide contents will also be evaluated. The goal of the analysis is to better understand the changes in polyethylene material properties that occur in vivo and ex vivo.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital
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Virginia
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Alexandria, Virginia, United States, 22306
- Anderson Orthopaedic Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Retrieved total hip arthroplasty liners maintained by the Anderson Orthopaedic Research Institute
- Crosslinked or conventional liners terminally sterilized without gamma-irradiation
Exclusion Criteria:
- Liners terminally sterilized with gamma-irradiation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Crosslinked polyethylene liners
Polyethylene liners from joint replacements that were crosslinked and heat treated to eliminate free radicals.
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Replacement of a patient's native hip with an artificial implant featuring a metal-on-polyethylene articulation
Other Names:
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Conventional polyethylene liners
Polyethylene liners from joint replacements that manufactured from conventional UHMWPE and terminally sterilized by methods that did not involve gamma-irradiation.
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Replacement of a patient's native hip with an artificial implant featuring a metal-on-polyethylene articulation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidation levels
Time Frame: At an average of 5 years in vivo
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Polyethylene oxidation levels will be quantified as a function of depth away from the articular and rim surfaces using Fourier Transform Infrared Spectroscopy (FTIR).
Pre and post-hexane and nitric oxide (NO) exposed post-hexane thin sections will be analyzed.
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At an average of 5 years in vivo
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absorbed lipids
Time Frame: At an average of 5 years in vivo
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Absorbed lipids will be evaluated by determining the level of carbonyls before and after hexane extraction using Fourier Transform Infrared Spectroscopy (FTIR).
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At an average of 5 years in vivo
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Crosslink density
Time Frame: At an average of 5 years in vivo
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Crosslink density will be evaluated using the gravimetric method on thin sections (~300μm) cut co-planar to the articular surfaces.
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At an average of 5 years in vivo
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Differential Scanning Calorimeter (DSC)
Time Frame: At an average of 5 years in vivo
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Differential Scanning Calorimeter (DSC) will be used to determine the 1st and 2nd heats, and 1st cool crystallinity, peak melting/crystallization points.
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At an average of 5 years in vivo
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Hydroperoxides
Time Frame: At an average of 5 years in vivo
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Hydroperoxides will be evaluated with FTIR by NO treatment after hexane extraction.
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At an average of 5 years in vivo
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Vinyl end-groups
Time Frame: At an average of 5 years in vivo
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Vinyl end-groups will be evaluated with FTIR after hexane extraction to quantify chain scission.
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At an average of 5 years in vivo
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Trans vinylene (TVI) unsaturations
Time Frame: At an average of 5 years in vivo
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Trans vinylene (TVI) unsaturations will be evaluated with FTIR after hexane extraction to determine radiation history and dose.
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At an average of 5 years in vivo
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Crystallinity
Time Frame: At an average of 5 years in vivo
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Infra-red crystallinity will be evaluated with FTIR after hexane extraction.
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At an average of 5 years in vivo
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Gel content
Time Frame: At an average of 5 years in vivo
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To quantify the extent of chain scission, gel content will be evaluated by measuring the non-extractable portion of the molecules using thin sections cut co-planar to the articular surfaces with a microtome and extracting the polyethylene chains from these sections in hot xylene.
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At an average of 5 years in vivo
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Robert H Hopper, Jr., PhD, Anderson Orthopaedic Research Institute
Publications and helpful links
General Publications
- Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty. 2011 Sep;26(6):825-31. doi: 10.1016/j.arth.2010.08.007. Epub 2010 Oct 2.
- 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.
- Muratoglu OK, Wannomae KK, Rowell SL, Micheli BR, Malchau H. Ex vivo stability loss of irradiated and melted ultra-high molecular weight polyethylene. J Bone Joint Surg Am. 2010 Dec 1;92(17):2809-16. doi: 10.2106/JBJS.I.01017.
- Bargmann LS, Bargmann BC, Collier JP, Currier BH, Mayor MB. Current sterilization and packaging methods for polyethylene. Clin Orthop Relat Res. 1999 Dec;(369):49-58. doi: 10.1097/00003086-199912000-00006.
- Currier BH, Van Citters DW, Currier JH, Collier JP. In vivo oxidation in remelted highly cross-linked retrievals. J Bone Joint Surg Am. 2010 Oct 20;92(14):2409-18. doi: 10.2106/JBJS.I.01006.
- Currier BH, Currier JH, Mayor MB, Lyford KA, Collier JP, Van Citters DW. Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups. J Bone Joint Surg Am. 2007 Sep;89(9):2023-9. doi: 10.2106/JBJS.F.00336.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AORI2011-0101
- MGH Agreement No: A208947 (Other Grant/Funding Number: DePuy Orthopaedics, Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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