Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

— MBT  

Official title:

Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398800
• Other study ID #: IIS-000113
• Status: Completed
• Start date: July 2011
• Est. completion date: July 30, 2019

Study information

• Verified date: October 2019
• Source: Colorado Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado Joint Replacement	DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function and knee score of the knee society scoring at every 2 years until 10 years.	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.	1-10 years post operative of revision
Secondary	Radiographic analysis by our orthopedic clinician to determine component failure or loosening.		Post op - 1-10 years or revision surgery