NCT05930067

Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ\_2018\_02 and DJS\_2019\_02, respectively).

Detailed description

The primary study objective is to establish the mean superior migration of the Pinnacle Gription Sector acetabular cup, irrespective of standard or dual mobility articulation, using model-based radiostereometric analysis. As both prior studies utilize the same acetabular component, a combined analysis will be performed with an additional sub-analysis on those with a Pinnacle Dual Mobility system. Additional objectives include comparison of acetabular cup migration between surgical approach groups (posterolateral, direct lateral, direct anterior) at all time points, linear head penetration at 1 and 2 years, as well as functional and health status outcomes. Patients will be followed to the original end point of 2 years post-surgery using the same radiographic and patient-reported outcome measures at the primary studies; Harris Hip Score, Hip Evaluation, HOOS Jr., and Forgotten Joint Score. Results of this study will be published in orthopaedic journals.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Pinnacle Gription Acetabular Cup	Pinnacle Gription cup with Corail/ACTIS stem
DEVICE	Pinnacle Dual Mobility	Bi-Mentum AltrX liner

Timeline

• Start date: 2023-05-02
• Primary completion: 2025-03-12
• Completion: 2025-05-30
• First posted: 2023-07-05
• Last updated: 2025-12-10

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study