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Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert T. Trousdale, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589108
First received: December 21, 2007
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of the knee. Total knee replacement may frequently be the only therapeutic intervention to provide adequate improvement in pain and function. Both fixed bearing and mobile bearing knees have a long track record of clinical success. Mobile bearing designs have theoretical advantages of decreased contact stresses on the tibial tray, decreased polyethylene wear, and improved range of motion relative to fixed bearing designs. These theoretical advantages may become especially important in the young patient who requires a knee arthroplasty. This study will attempt to see if there is a clinical difference in outcome between mobile bearing and fixed bearing knee arthroplasties in patients who require total knee replacement.


Condition Intervention
Degenerative Joint Disease
Device: Sigma Knee System
Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray
Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study Comparing A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Maximum Knee Flexion [ Time Frame: 2 years post-surgery, 5 years post-surgery ] [ Designated as safety issue: No ]
    The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.


Secondary Outcome Measures:
  • Knee Society Function Score [ Time Frame: 5 years post surgery ] [ Designated as safety issue: No ]
    The Knee Society Function Score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. The minimum function score is 0.

  • Knee Society Pain Score [ Time Frame: 5 years post-surgery ] [ Designated as safety issue: No ]
    The Knee Society Pain Score includes walking and climbing stairs. The maximum score per knee is 50 indicating no pain, and 0 indicates severe pain. Therefore the total score (for both knees) could range from 0 to 100.

  • Knee Society Stair Climbing Score [ Time Frame: two years post-surgery, five years post-surgery ] [ Designated as safety issue: No ]
    The stair-climbing portion of the Knee Society clinical rating system assigns a maximum score of 50 points for patients able to ascend and descend stairs in a normal fashion, 40 points for patients needing a rail to descend, 30 points for patients using a rail in both directions, 15 points for patients able to ascend but not descend at all, and 0 points for patients unable ascend or descend. Because stair ascent and descent put substantial demands on the patellofemoral joint, we used that portion of the Knee Society clinical rating system as a proxy for patellofemoral function in this study.

  • Percentage of Knees Surviving at 5 Years [ Time Frame: 5 years post-surgery ] [ Designated as safety issue: No ]
    Kaplan-Meier analysis of five-year implant survival rate


Enrollment: 240
Study Start Date: January 2001
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mobile-Bearing Knee
Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
Device: Sigma Knee System
Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
Other Names:
  • Sigma Knee System
  • Sigma Rotating Platform Knee System
Active Comparator: Modular-Metal-Backed Knee
Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray
Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
Other Name: Press-Fit Condylar Total Knee Arthroplasty
Active Comparator: All-Polyethylene Knee
Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray)

Detailed Description:

This prospective, randomized, single-blinded clinical trial compared a mobile-bearing total knee system with two types of fixed-bearing total knee systems in patients undergoing cemented total knee arthroplasty. The devices to be used are FDA approved: the Sigma Knee System (mobile-bearing), the Sigma, Pressfit Condylar posterior cruciate substituting (fixed-bearing) system with a metal backed tibial tray, and the Sigma press-fit condylar posterior cruciate substituting system (fixed bearing) with an all polyethylene tibial tray.

The surgical procedures were performed by 4 experienced orthopedic surgeons with a subspecialty interest in total knee arthroplasty. A midline skin incision and medial parapatellar arthrotomy were used to expose the knee. The distal femoral resection was performed with an intramedullary alignment guide, and the proximal tibial resection was performed with an extramedullary alignment guide. Knees with fixed deformities had a surgical release of the contracted tissues on the medial or lateral side, as appropriate, to obtain symmetric balance of the total knee replacement in both flexion and extension. The flexion and extension gaps and the medial and lateral soft-tissue structures were balanced in accordance with standard techniques.

Patients began progressive weight-bearing on the first postoperative day, and active knee range of motion was initiated with 24 hours after surgery. Patients were typically discharged on the fourth or fifth postoperative day after obtaining the ability to walk with a walker, to ascend several stairs, and to flex the knee 290 degrees. Patients were asked to return for examination and radiographs at 3 months, 1 year, 2 years, and 5 years after surgery.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing unilateral primary knee surgery for degenerative joint disease (DJD).

Exclusion Criteria:

  • Severe deformity greater than or equal to 20 degrees varus, valgus malalignment
  • Osteomyelitis, septicemia, or other active infections that may spread to other areas of the body
  • The presence of infections, highly communicable diseases, e.g., AIDS, active tuberculosis, venereal disease, hepatitis
  • Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing
  • Metastatic disease
  • Any congenital, developmental, or other bone disease or previous knee surgery that may, in the surgeon's judgement, interfere with total knee prosthesis survival or success, e.g., Paget's disease, Charcot's disease secondary to diabetes, severe osteoporosis, previous high tibial osteotomy, etc.
  • Presence of previous prosthetic knee replacement device (any type)
  • Arthrodesis of the affected knee
  • Patients not requiring patella resurfacing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589108

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robert T Trousdale, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Robert T. Trousdale, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00589108     History of Changes
Other Study ID Numbers: 271-01
Study First Received: December 21, 2007
Results First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
knee arthroplasty

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

ClinicalTrials.gov processed this record on November 20, 2014