Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis Clinical Trial
Official title:
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows: Primary endpoint: The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan. Secondary endpoints: 1. Inclination success (as defined for the primary endpoint) 2. Version success (as defined for the primary endpoint) 3. 90-day complication rates 4. Change from preoperative baseline for the Harris Hip Score 5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral) 6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable) 7. Change from 6 week baseline for the Forgotten Joint Score ;