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Clinical Trials/NCT01425021
NCT01425021
Completed
Not Applicable

Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

University of Utah1 site in 1 country199 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Joint Revisions
Sponsor
University of Utah
Enrollment
199
Locations
1
Primary Endpoint
determine the mechanism of material failure
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The goal of this is to improve durability of total joint replacements in patients, thereby improving clinical outcomes and implant performance. To reach this objective, our research program would like to assess the safety, efficacy, performance, and durability of FDA approved biomaterial and implant designs used in joint replacements.

Detailed Description

The objective of the investigation will be to determine the mechanism of material failure and identify any design features that put the implant at risk for early failure. Normally all implants are discarded. The investigators will collect the implants indicated for removal and if there are impressive findings the investigators will perform research on the implants, otherwise the implants will be discarded. All patients will be followed prospectively after informed consent is signed. The implants that are chosen for research will be assessed for implant wear and failure at a lab appropriate for evaluating the particular concern.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
May 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Peters

M.D.

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Patients who will be undergoing revision total joint surgery will be asked to participate in this study.

Exclusion Criteria

  • Patients who are not undergoing revision total joint surgery.

Outcomes

Primary Outcomes

determine the mechanism of material failure

Time Frame: 10 years

Secondary Outcomes

  • identify any design features that put the implant at risk for early failure.(10 years)

Study Sites (1)

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