Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Christopher Peters, University of Utah
ClinicalTrials.gov Identifier:
NCT01425021
First received: August 25, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition
Total Joint Revisions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • determine the mechanism of material failure [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • identify any design features that put the implant at risk for early failure. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
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)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing revision total joint surgery.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425021

Locations
United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Chris Peters, MD University of Utah
  More Information

No publications provided

Responsible Party: Christopher Peters, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01425021     History of Changes
Other Study ID Numbers: 43277
Study First Received: August 25, 2011
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014