Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
A Prospective, Randomized, Controlled Study Comparing A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
January 16, 2013
CompletedJanuary 16, 2013
December 1, 2012
10.3 years
December 21, 2007
December 10, 2012
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Knee Flexion
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.
2 years post-surgery, 5 years post-surgery
Secondary Outcomes (4)
Knee Society Function Score
5 years post surgery
Knee Society Pain Score
5 years post-surgery
Knee Society Stair Climbing Score
two years post-surgery, five years post-surgery
Percentage of Knees Surviving at 5 Years
5 years post-surgery
Study Arms (3)
Mobile-Bearing Knee
ACTIVE COMPARATORSigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
Modular-Metal-Backed Knee
ACTIVE COMPARATORSigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
All-Polyethylene Knee
ACTIVE COMPARATORSigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
Interventions
Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray)
Eligibility Criteria
You may qualify if:
- Patients undergoing unilateral primary knee surgery for degenerative joint disease (DJD).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 22437996RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert T. Trousdale
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Robert T Trousdale, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 9, 2008
Study Start
January 1, 2001
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 16, 2013
Results First Posted
January 16, 2013
Record last verified: 2012-12