Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

August 17, 2015 updated by: Christopher Peters, University of Utah
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing revision total joint surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determine the mechanism of material failure
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
identify any design features that put the implant at risk for early failure.
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Chris Peters, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 43277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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