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Analysis of Crosslinked and Conventional Polyethylene Explants

NCT01484002 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-01-24

No results posted yet for this study

Summary

This retrospective study will investigate the changes that occur in ultrahigh molecular weight polyethylene (UHMWPE) implants that have been retrieved from joint replacement patients. 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 objective is to characterize the in vivo and ex vivo changes that occur with cross-linked and conventional polyethylene bearings sterilized by methods that do not involve radiation. The investigators hypothesize that polyethylene absorbs lipids in vivo but experiences negligible oxidation or reductions in polymer crosslinking until it is explanted and stored at room temperature with access to ambient air.

Conditions

Interventions

DEVICE

Total hip arthroplasty

Replacement of a patient's native hip with an artificial implant featuring a metal-on-polyethylene articulation

Sponsors & Collaborators

  • Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital

    collaborator UNKNOWN

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Anderson Orthopaedic Research Institute

    lead OTHER

Principal Investigators

  • Robert H Hopper, Jr., PhD · Anderson Orthopaedic Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484002 on ClinicalTrials.gov