Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

NCT ID: NCT01425021

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Total Joint Revisions

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Christopher Peters

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris Peters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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43277

Identifier Type: -

Identifier Source: org_study_id

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