NCT05591859

Restoration Anatomic Acetabular Shell Revision Study

Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.

Conditions

• Arthropathy
• Hip Arthropathy
• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Restoration Anatomic Acetabular Shell	Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.

Timeline

• Start date: 2024-03-02
• Primary completion: 2036-03-01
• Completion: 2036-03-01
• First posted: 2022-10-24
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study