Analysis of Crosslinked and Conventional Polyethylene Explants

Status unconfirmed

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID: NCT01484002
Run by: Anderson Orthopaedic Research Institute
People needed: 60
Starts: 2011-12-01
Expected to finish: 2017-12-01
Last updated by the study team: 2017-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Retrieved total hip arthroplasty liners maintained by the Anderson Orthopaedic Research Institute
Crosslinked or conventional liners terminally sterilized without gamma-irradiation

You may not qualify if…

Liners terminally sterilized with gamma-irradiation

Where it is running

Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital — Boston, Massachusetts, United States
Anderson Orthopaedic Research Institute — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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