NCT04070989

Pinnacle RSA Study

Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.

Conditions

• Osteoarthritis
• Degenerative Arthritis

Interventions

Type	Name	Description
DEVICE	THA	Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Timeline

• Start date: 2019-12-03
• Primary completion: 2023-06-12
• Completion: 2023-06-16
• First posted: 2019-08-28
• Last updated: 2025-12-19
• Results posted: 2025-10-21

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated device study