The verification study on correlative relationship between bone resection volume and outcomes in the TKA with .Triathlon CR/PS and Advanced-Gap-Sezer.
- Conditions
- Knee osteoarthritis
- Registration Number
- JPRN-UMIN000022555
- Lead Sponsor
- Stryker Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 208
Not provided
1) Patients have bacterial infectious disease or have risk highly of bacterial infection. 2) Patients requiring revision surgery. 3) Patients, who are severe Baker's leg (FTA < 165 degree). 4) Patients had bone osteotomy to tibia. 5) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40. 6) Patients who is pregnant female or maybe so. 7) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 8) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy). 9) Patients who are immunologically suppressed or receiving chronic steroids. 10) Patients who are judged ineligible with reasonable reason by primary doctor.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiographic evaluation. Functional Score. Patients satisfaction.
- Secondary Outcome Measures
Name Time Method