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OpenTrials
Completed

NCT Number: NCT01425021

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.

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Key information

Conditions

Total Joint Revisions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. determine the mechanism of material failure

    Time frame: 10 years

Secondary outcomes

  1. identify any design features that put the implant at risk for early failure.

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 29, 2011
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.