Multicenter clinical study to assess the effectiveness and safety of Trident II in total hip arthroplasty (THA)
- Conditions
- Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, fracture
- Registration Number
- JPRN-UMIN000043715
- Lead Sponsor
- Stryker Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 191
Not provided
Subjects enrolled prospectively 1.Revision THA 2.Patient is pregnant or potentially pregnant. 3. Patient is immunologically suppressed or receiving steroids which limits the ability to evaluate radiography on this study. 4. Patient is determined to be unsuitable for other obvious reasons by the investigator. 5.Patient have participated in another clinical trial, clinical study with intervention or clinical study sponsored by other pharmaceutical/medical device companies, or plans to participate them. Subjects enrolled retrospectively 1.Revision THA 2.Patient is pregnant or potentially pregnant. 3. Patient is immunologically suppressed or receiving steroids which limits the ability to evaluate radiography on this study. 4. Patient have participated in another clinical trial, a clinical study with intervention or a clinical study sponsored by other health care companies during the period to collect the data for this study. 5. Normal medical information is available up to immediately after surgery.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness: To evaluate the fixability and stability by radiographic evaluations (Radiolucent line, Spot welds, Bone ingrowth, Early fixation)
- Secondary Outcome Measures
Name Time Method Effectiveness: Clinical outcome(JHEQ,JOA score) Dislocation/Revision rate Safety Safety information (Adverse event, Malfunction)