NCT03189303

Cup Position in THA With Standard Instruments

Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Primary Uncemented Total Hip Arthroplasty	The study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem

Timeline

• Start date: 2017-09-07
• Primary completion: 2021-05-19
• Completion: 2021-12-14
• First posted: 2017-06-16
• Last updated: 2022-02-15

Locations

11 sites across 4 countries: United States, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study