Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
Primary Purpose
Osteoarthritis, Knee
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TKA surgery with the rotating platform mobile-bearing knee design
TKA surgery with the all-polyethylene tibia knee design
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee arthritis, total knee arthroplasty, total knee replacement, mobile bearing design, all-polyethylene tibia
Eligibility Criteria
Inclusion Criteria:
- generally accepted clinical and radiographic criteria for primary total knee arthroplasty
Exclusion Criteria:
- substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
- patients whose mental function precluded them from responding to our standard questionnaires
Sites / Locations
- Minneapolis VAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
rotating-platform design TKA
all-polyethylene tibia design TKA
Arm Description
patients who were randomized to receive the rotating platform mobile-bearing TKA design
patients who were randomized to receive the all-polyethylene tibial component design
Outcomes
Primary Outcome Measures
Knee Postoperative Range of Motion (ROM) at 2 Years
range of motion of the knee postoperatively at 2 years
Secondary Outcome Measures
Survival of the Implants to Subject Death or Implant Removal
Full Information
NCT ID
NCT00894361
First Posted
March 24, 2009
Last Updated
September 3, 2020
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Depuy, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00894361
Brief Title
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
Official Title
A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
Study Start Date
October 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Depuy, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee arthritis, total knee arthroplasty, total knee replacement, mobile bearing design, all-polyethylene tibia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rotating-platform design TKA
Arm Type
Active Comparator
Arm Description
patients who were randomized to receive the rotating platform mobile-bearing TKA design
Arm Title
all-polyethylene tibia design TKA
Arm Type
Active Comparator
Arm Description
patients who were randomized to receive the all-polyethylene tibial component design
Intervention Type
Procedure
Intervention Name(s)
TKA surgery with the rotating platform mobile-bearing knee design
Intervention Description
Depuy Sigma RP rotating platform design
Intervention Type
Procedure
Intervention Name(s)
TKA surgery with the all-polyethylene tibia knee design
Intervention Description
Depuy Sigma fixed-bearing design with all-polyethylene tibia
Primary Outcome Measure Information:
Title
Knee Postoperative Range of Motion (ROM) at 2 Years
Description
range of motion of the knee postoperatively at 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Survival of the Implants to Subject Death or Implant Removal
Time Frame
10 or more years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
generally accepted clinical and radiographic criteria for primary total knee arthroplasty
Exclusion Criteria:
substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
patients whose mental function precluded them from responding to our standard questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence J Gioe, M.D.
Organizational Affiliation
Minneapolis VAMC, Dept. of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19723986
Citation
Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.
Results Reference
result
Learn more about this trial
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
We'll reach out to this number within 24 hrs