Patients with hip pain and dysfunction who have been diagnosed to require hip replacement.
Conditions
Interventions
Implantation of TM Cup by THA.
Sponsors
Zimmer K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) A patient with hip pain and dysfunction who has been diagnosed to require THA and to be indicated for a cementless fixation at the acetabular side. (2) A patient who understands the purpose of this clinical study and has provided a written consent. (3) A patient who may be followed up for 12 months postoperatively.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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. | — |
Countries
Japan
Outcome results
None listed