NIPH Clinical Trials Search

Clinical Study of TM-Tibia/Patella

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Patients with knee pain and dysfunction who have been diagnosed to require knee replacement
Date of first enrollment	2004/06/01
Target sample size	76
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Implantation of TM-Tibia/Patella by TKA

Outcome(s)

Primary Outcome

(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

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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.