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

NCT ID: NCT00589108

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2011-05-31

Brief Summary

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.

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.

Conditions

Degenerative Joint Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mobile-Bearing Knee

Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)

Group Type: ACTIVE_COMPARATOR

Sigma Knee System

Intervention Type: DEVICE

Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)

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)

Group Type: ACTIVE_COMPARATOR

Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray

Intervention Type: DEVICE

Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)

All-Polyethylene Knee

Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray

Group Type: ACTIVE_COMPARATOR

Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray

Intervention Type: DEVICE

Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray)

Interventions

Sigma Knee System

Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DEVICE

Other Intervention Names

Sigma Rotating Platform Knee System; Press-Fit Condylar Total Knee Arthroplasty

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Robert T. Trousdale

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert T Trousdale, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Kalisvaart MM, Pagnano MW, Trousdale RT, Stuart MJ, Hanssen AD. Randomized clinical trial of rotating-platform and fixed-bearing total knee arthroplasty: no clinically detectable differences at five years. J Bone Joint Surg Am. 2012 Mar 21;94(6):481-9. doi: 10.2106/JBJS.K.00315.

Reference Type: RESULT

PMID: 22437996 (View on PubMed)

Other Identifiers

271-01

Identifier Type: -

Identifier Source: org_study_id