Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00894361|
Recruitment Status : Terminated (PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed)
First Posted : May 7, 2009
Results First Posted : May 7, 2009
Last Update Posted : September 7, 2020
This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:
- Does a RP design offer improvement in range of motion over a AP design?
- Does a RP design have improved wear characteristics over a nonmodular AP design?
- Is there a clear clinical advantage to the RP design that justifies its increased cost?
Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.
This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: TKA surgery with the rotating platform mobile-bearing knee design Procedure: TKA surgery with the all-polyethylene tibia knee design||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
Active Comparator: rotating-platform design TKA
patients who were randomized to receive the rotating platform mobile-bearing TKA design
Procedure: TKA surgery with the rotating platform mobile-bearing knee design
Depuy Sigma RP rotating platform design
Active Comparator: all-polyethylene tibia design TKA
patients who were randomized to receive the all-polyethylene tibial component design
Procedure: TKA surgery with the all-polyethylene tibia knee design
Depuy Sigma fixed-bearing design with all-polyethylene tibia
- Knee Postoperative Range of Motion (ROM) at 2 Years [ Time Frame: 2 years ]range of motion of the knee postoperatively at 2 years
- Survival of the Implants to Subject Death or Implant Removal [ Time Frame: 10 or more years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894361
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Terence J Gioe, M.D.||Minneapolis VAMC, Dept. of Orthopaedic Surgery|