Clinical Study of TM-Tibia/Patella
Phase 3
- Conditions
- Patients with knee pain and dysfunction who have been diagnosed to require knee replacement
- Registration Number
- JPRN-UMIN000004102
- Lead Sponsor
- Zimmer K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Not provided
Exclusion Criteria
(1)A patient with a previous history of infection in the affected joint. (2)A patient with insufficient bone stock on tibial, femoral or patellar surfaces. (3)A patient with a skeletal immaturity. (4)A patient with neuropathic arthropathy. (5)A patient with infection-like symptoms. (6)A patient with rheumatoid arthritis with a previous history of skin ulcer or recurrent skin breakdown. (7)A patient with osteoporosis or a neuromuscular disease that may compromise the affected limbs. (8)A patient with severe instability secondary to absence of a collateral ligament. (9)A patient who has been judged ineligible for the conduct of the study by the study investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1)Efficacy evaluation Efficacy evaluation was performed using the following four categories of evaluation criteria based on the improvement rate by the JOA score and X-ray evaluation at 12 months postoperatively; Markedly effective, Effective, Slightly effective and Ineffective (2) Safety evaluation The clinical safety was evaluated based on the following four categories by comprehensively considering the adverse events; Safe, Almost safe, Insufficiently safe and Not safe (3) Usefulness evaluation The usefulness was judged according to the following five categories based on the matrix of efficacy and safety evaluation; Very useful, Useful,Slightly useful, Not useful and Contraindicated
- Secondary Outcome Measures
Name Time Method