Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery
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.
Total Joint Revisions
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery|
- determine the mechanism of material failure [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- identify any design features that put the implant at risk for early failure. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Total hip/knee joint revisions
All University of Utah orthopedic patients who have had total or partial joint arthroplasties at the time of revision surgery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425021
|United States, Utah|
|University of Utah Orthopaedic Center|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Chris Peters, MD||University of Utah|