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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894361
First Posted: May 7, 2009
Last Update Posted: July 30, 2013
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.
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Knee Postoperative Range of Motion (ROM) at 2 Years [ Time Frame: 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 [ Time Frame: 10 or more years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Publications:
Responsible Party: Terence J. Gioe, M.D., Chief, Dept. of Orthopaedic Surgery, Minneapolis VAMC, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00894361     History of Changes
Other Study ID Numbers: MVA-3028
First Submitted: March 24, 2009
First Posted: May 7, 2009
Results First Submitted: March 24, 2009
Results First Posted: May 7, 2009
Last Update Posted: July 30, 2013
Last Verified: June 2013

Keywords provided by Terence J. Gioe, M.D., 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