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Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

This study has been completed.
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00894361
First received: March 24, 2009
Last updated: May 15, 2009
Last verified: May 2009
History of Changes
  Purpose

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:

  1. Does a RP design offer improvement in range of motion over a AP design?
  2. Does a RP design have improved wear characteristics over a nonmodular AP design?
  3. 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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Knee Postoperative ROM at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival of the Implants to Subject Death or Implant Removal [ Time Frame: 10 or more years ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: October 2001
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894361

Locations
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Depuy, Inc.
Investigators
Principal Investigator: Terence J Gioe, M.D. Minneapolis VAMC, Dept. of Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: Terence J. Gioe, M.D., Chief, Dept. of Orthopaedic Surgery, Minneapolis VAMC
ClinicalTrials.gov Identifier: NCT00894361     History of Changes
Other Study ID Numbers: MVA-3028
Study First Received: March 24, 2009
Results First Received: March 24, 2009
Last Updated: May 15, 2009
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
knee arthritis
total knee arthroplasty
total knee replacement
mobile bearing design
all-polyethylene tibia

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013