N/A
Completed N=149
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
Osteoarthritis · Rheumatoid Arthritis · Other Inflammatory Arthritis · Post-Traumatic Arthritis
Source: ClinicalTrials.gov NCT00289107 ↗
Enrolled (actual)
149
Serious AEs
14.1%
Results posted
Dec 2010
Primary outcomePrimary: Knee Society Score — 39.3; 37.2; 90.8; 89.2 Scores on a scale
Summary
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Score |
39.3; 37.2; 90.8; 89.2; 96.1; 93.0 | — |
| SECONDARY Complications |
— | — |
| SECONDARY Revisions |
— | — |
| SECONDARY Medical Imaging |
— | — |
| SECONDARY SF-12 Patient Outcomes |
— | — |
Eligibility Criteria
Inclusion Criteria
- Osteoarthritis
- Rheumatoid arthritis
- Other inflammatory arthritis
- Avascular necrosis (AVN) of bone
- Post-Traumatic Arthritis
- Juvenile Rheumatoid Arthritis
Exclusion Criteria
- History of recent/active joint sepsis.
- Charcot neuropathy.
- Psycho-social disorders that would limit rehabilitation.
- Greater than 75 years of age at the time of surgery.
- Prior ipsilateral knee arthroplasty.
- Metabolic disorders of calcified tissues, such as Paget's disease.
- Severe diabetes mellitus.
- Joint replacement due to autoimmune disorders.
- Skeletal immaturity
Data sourced from ClinicalTrials.gov (NCT00289107). 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. Informational only — not medical advice.