Patients who have been judged to require THA
Conditions
Interventions
Implantation of components by THA
Sponsors
Zimmer K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient is skeletally mature. 2) The patient has a JOA Pain Score =< 20 and a JOA Total Score =< 50, and has been diagnosed to require THA. 3) The patient has one or more of the following diseases that require THA: (1) Osteonecrosis of the femoral head (2) Osteoarthritis (3) Rheumatoid arthritis 4) The patient has not had THA or arthrodesis. 5) The patient is able to provide his/her own consent to participate in the study in a written form.
Exclusion criteria
Exclusion criteria: 1) The patient is a known alcohol or drug abuser. 2) The patient has a neuromuscular disorder, vascular disorder or other condition that could cause implant instability, implant fixation failure, or postoperative complications. 3) The patient has a vascular insufficiency (large and small vessel disease), renal impairment, or renal failure. 4) The patient has initiated a chronic administration of systemic or inhaled steroid within 3 months. 5) The patient has a neurologic condition that could affect the function of the lower limbs. 6) The patient needs to be corrected a leg length discrepancy >= 3.2 cm. 7) The patient has a systemic disease that could affect his/her safety or the study outcome. 8) The patient has a contagious disease and is difficult to continue observation/investigation. 9) The patient is known to be pregnant. 10) The patient has received an investigational drug or other investigational device within the previous 6 months. 11) The patient has an active or latent infection in or about the affected hip joint or an infection distant from the affected hip joint that may spread to the affected joint hematogenously. 12) The patient has a known sensitivity or allergic reaction to any of the materials of the joint prosthesis including metal and ceramic. 13) The patient has an acute fracture in the affected femoral head that requires THA. 14) The patient has undergone THA, revision surgery or surface arthroplasty of the contralateral hip within the previous 6 months. 15) The patient has had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. 16) The patient has insufficient bone stock to fix the hip prostheses. 17) The patient has a local bone tumor or cyst in the affected hip joint. 18) The patient has a Body Mass Index (BMI) >35.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Improvement ratings: Evaluated based on changes in JOA scores at 6 months post-THA from baseline (before THA) according to the criteria . 2) Safety ratings : Evaluated based on details of failures/device-related adverse events (including revision cases) reported during 6 months post-THA according to the criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluations at 6 months post-THA 1) Safety ratings. 2) Morphological stability. 3) Improvements in JOA scores and SF-12 (QOL) questionnaire scores. Evaluations at 2 years of follow-up 1) Failures/adverse events. 2) Morphological stability. 3) Improvements in JOA scores and SF-12 (QOL) questionnaire scores. | — |
Countries
Japan
Contacts
Public ContactMikiharu Morita
Zimmer K.K. Clinical Research Dept.
Outcome results
None listed