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

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00589108

Purpose

A prospective, randomized, single-blinded clinical trial is proposed to compare 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.

Eighty cases will be assigned to each arm of the study. Each patient will be assessed two months after surgery, one year after surgery, two years after surgery, five years after surgery, and every three to five years thereafter. The principal outcome measures will be the Knee Society Clinical rating scale and the SF-12. The result for these will be analyzed using students' t-test analysis, taking into account classification by demographic variables.

Chi-square analysis will be used to compare the instance of mortality, revision surgery, deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection. Other outcome measures incorporated in the Knee Society Clinical rating scale will undergo appropriate generalized linear regression for the type of outcome involved.

Condition	Intervention
Knee	Device: Sigma Knee System Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray

MedlinePlus related topics: Knee Replacement Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The primary aim of the study is to compare the results of a mobile-bearing total knee system with a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. [ Time Frame: 2 months; 1, 2 and 5 years ] [ Designated as safety issue: No ]

Enrollment:	240
Study Start Date:	January 2001
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 80 patients receiving the 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)
2: Active Comparator Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tilbial tray (fixed-bearing knee with the metal backed tray)	Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tilbial tray (fixed-bearing knee with the metal backed tray)
3: Active Comparator Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an 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:

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 knee arthroplasty.

Eligibility

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

Criteria

Inclusion Criteria:

Patients 40 and 75 undergoing unilateral primary knee surgery for degenerative joint disease (DJD).

Exclusion Criteria:

Age less than 40 years or 75.
Severe deformity 20 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 TK 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

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:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Robert T. Trousdale, MD )
Study ID Numbers:	271-01
Study First Received:	December 21, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00589108 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 07, 2009