Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

NCT ID: NCT01398800

Last Updated: 2019-10-24

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

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2019-07-30

Brief Summary

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Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile bearings in the revision TKA setting include reduction in polyethylene wear, decreasing fixation stresses, and protection of the constraining mechanisms. Several studies have reported satisfactory clinical results after revision total knee arthroplasty but no study with a large number has specifically addressed the clinical outcomes after revision total knee arthroplasty using the mobile bearing design

Detailed Description

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Failure modes of revision total knee arthroplasty (TKA) that include prosthetic loosening and damage to constraining mechanisms often require revision TKA. Mobile bearing revision TKA components have been developed in hopes of lessening these failure mechanisms. Our purpose is to evaluate the use of mobile bearings in revision TKA.

Retrospective clinical and radiographic evaluation of 340 revision mobile bearing TKAs using the PFC Sigma and LCS posterior stabilized rotating platform implants (Depuy, Warsaw, IN) will be performed. Indications for revision include instability, loosening, arthrofibrosis, chronic hemarthrosis, failed patellofemoral replacement, failed unicompartmental knee replacement, infection reimplantation, and supracondylar fracture nonunion.

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Requiring a revision of a primary knee replacement. Indications for revision include instability, aseptic loosening, failed unicompartmental knee replacement, infection reimplantation, arthrofibroisis, chronic hemarthrosis, failed patellofemoral replacments, and non union of a supracondylar femur fracture.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

Colorado Joint Replacement

OTHER

Sponsor Role lead

Responsible Party

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Donnis Rafferty

Dr. Raymond Kim

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement

Locations

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Colorado Joint Replacement

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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IIS-000113

Identifier Type: -

Identifier Source: org_study_id

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