NIPH Clinical Trials Search

UMIN ID: UMIN000002949

Registered date:31/05/2010

General clinical study of acetabular cup (TM Cup) for total hip arthroplasty

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with hip pain and dysfunction who have been diagnosed to require hip replacement.
Date of first enrollment2003/10/01
Target sample size75
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Implantation of TM Cup by THA.


Primary Outcome(1) Efficacy evaluation based on the evaluations of the X-ray images (radiolucent zones) and JOA score at postoperative 12 months. (2) Safety evaluation Adverse events up to postoperative 12 months. (3) Usefulness evaluation according to the matrix of efficacy and safety results.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria(1)A patient with a previous history of infection in the affected joint. (2)A patient with an immature bone structure. (3)A patient with neuropathic arthropathy. (4)A patient with infection-like symptoms. (5)A patient with rheumatoid arthritis with a previous history of skin ulcer or recurrent skin breakdown. (6)A patient with osteoporosis or neuromuscular disease that may compromise the affected limbs. (7)A patient with severely unstable hip joint due to a decreased muscular or ligamentous support. (8)A patient who has been judged ineligible for the conduct of the study by the study investigator.

Related Information


public contact
Address 4-1-17 Toranomon, Minato-ku, Tokyo Japan
Affiliation Zimmer K.K. Clinical Affairs
scientific contact
Name Yukihide Iwamoto, MD
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka Japan
Affiliation Kyusyu University Hospital Department of Orthopaedic Surgery