Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

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

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Key information

Conditions

Arthroplasty, Replacement, Knee

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Exclusion criteria

None since they have all required a revision.

Treatment and study plan

Primary outcomes

Function and knee score of the knee society scoring at every 2 years until 10 years.

Time frame: 1-10 years post operative of revision

Follow up data of 1,2,4,6,8,and 10 years to evaluate bearing complications and clinical results for the use of MB in revision TKA. Retrospective clinical and radiographic evaluation of 197 mobile bearing revision TKA's will be collected. We will also analyze patient demographics and reason for revisions as well as implants used in revision.

Secondary outcomes

Radiographic analysis by our orthopedic clinician to determine component failure or loosening.

Time frame: Post op - 1-10 years or revision surgery

Sponsors and collaborators

Lead sponsor

Colorado Joint Replacement

Other

Collaborators

DePuy Orthopaedics

Registry information

Acronym: MBT

Important dates

Study start: 2011
Primary completion: 2019
Study completion: 2019
First posted: Jul 21, 2011
Registry last updated: Oct 24, 2019

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.

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