N/A
N=240
Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
Degenerative Joint Disease
Bottom Line
View on ClinicalTrials.gov: NCT00589108 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Maximum Knee Flexion — 110; 111; 111; 109.0 degrees — p=0.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Knee Flexion |
110; 111; 111; 109.0; 109; 110.0 | 0.64 |
| SECONDARY Knee Society Function Score |
69.2; 77.4; 69.7 | 0.06 |
| SECONDARY Knee Society Pain Score |
87.8; 88.7; 88.3 | 0.87 |
| SECONDARY Knee Society Stair Climbing Score |
39; 40; 39; 36; 40; 37 | 0.44 |
| SECONDARY Percentage of Knees Surviving at 5 Years |
98.7; 97.4; 98.7; 100; 97.4; 98.7 | 0.92 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00589108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.