Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, fracture
Conditions
Interventions
None listed
Sponsors
Stryker Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects enrolled prospectively 1. Patient is a candidate for primary THA with Trident II, or underwent primary THA with Trident II. 2. Patient is diagnosed with Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, Rapidly Destructive Coxarthropathy, Fracture. 3.Patient is 20 years of age or older at the time of surgery. 4. Patient has signed an Informed Patient Consent Form. Subjects enrolled retrospectively 1. Patient underwent primary THA with Trident II. 2. Patient is diagnosed with Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, Rapidly Destructive Coxarthropathy, Fracture. 3.Patient is 20 years of age or older at the time of surgery. 4. It is unable to obtain consent from the study candidate for reasons such as difficulty in visiting the hospital for follow-up, and the patient did not refuse to participate in the study by opting out by herself/himself or their alternates.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: To evaluate the fixability and stability by radiographic evaluations (Radiolucent line, Spot welds, Bone ingrowth, Early fixation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness: Clinical outcome(JHEQ,JOA score) Dislocation/Revision rate Safety Safety information (Adverse event, Malfunction) | — |
Countries
Japan
Contacts
Public ContactKenta Suzuki
Stryker Japan K.K. Clinical Affairs
Outcome results
None listed