We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425021
First Posted: August 29, 2011
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Peters, University of Utah
  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 Christopher Peters, University of Utah:

Primary Outcome Measures:
  • determine the mechanism of material failure [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • identify any design features that put the implant at risk for early failure. [ Time Frame: 10 years ]

Enrollment: 199
Study Start Date: August 2010
Study Completion Date: May 2015
Primary Completion Date: May 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christopher Peters, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01425021     History of Changes
Other Study ID Numbers: 43277
First Submitted: August 25, 2011
First Posted: August 29, 2011
Last Update Posted: August 19, 2015
Last Verified: August 2015