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UMIN ID: UMIN000004102

Registered date:25/08/2010

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

TO Original Data: UMIN

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

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.

Related Information

Primary Sponsor	Zimmer K.K.
Secondary Sponsor
Source(s) of Monetary Support	Zimmer K.K.
Secondary ID(s)

Contact

public contact
Name	Mikio Ishikawa
Address	4-1-17 Toranomon, Minato-ku, Tokyo Japan
Telephone	03-6402-6671
E-mail
Affiliation	Zimmer K.K. Clinical Affairs
scientific contact
Name	Kenji Nakagawa, MD
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake-shi, Aichi Japan
Telephone
E-mail
Affiliation	Former Fujita Health University Department of Orthopaedic Surgery

TO Original Data: UMIN