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) studied | Patients with hip pain and dysfunction who have been diagnosed to require hip replacement. |
| Date of first enrollment | 2003/10/01 |
| Target sample size | 75 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Implantation of TM Cup by THA. |
Outcome(s)
| 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 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 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
| Primary Sponsor | Zimmer K.K. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Zimmer K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 4-1-17 Toranomon, Minato-ku, Tokyo Japan |
| Telephone | |
| Affiliation | Zimmer K.K. Clinical Affairs |
| scientific contact | |
| Name | Yukihide Iwamoto, MD |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka Japan |
| Telephone | |
| Affiliation | Kyusyu University Hospital Department of Orthopaedic Surgery |