MedPath

Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

Completed
Conditions
Total Joint Revisions
Registration Number
NCT01425021
Lead Sponsor
University of Utah
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
199
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
determine the mechanism of material failure10 years
Secondary Outcome Measures
NameTimeMethod
identify any design features that put the implant at risk for early failure.10 years

Trial Locations

Locations (1)

University of Utah Orthopaedic Center

🇺🇸

Salt Lake City, Utah, United States

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