Restoration Anatomic Acetabular Shell Revision Study

Not Applicable

Recruiting

• Conditions: Hip Osteoarthritis; Arthropathy; Hip Arthropathy
• Interventions: Device: Restoration Anatomic Acetabular Shell

• Registration Number: NCT05591859
• Lead Sponsor: Stryker Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Study Start: 2024-03-02
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2036-03-01
• Study Completion: 2036-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
• Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
• Subject is skeletally mature.
• Subject is a male or non-pregnant female.
• Subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria

• Subject has a non-Stryker retained stem at the time of study device implantation.
• Subject has a Body Mass Index (BMI) > 45.
• Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
• Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
• Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
• Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. > 30 days).
• Subject has a known sensitivity to device materials.
• Subject is a prisoner.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restoration Anatomic Acetabular Shell	Restoration Anatomic Acetabular Shell	-

Primary Outcome Measures

Name	Time	Method
Success rate	10 years	Success rate is defined as no incidence of revision for aseptic loosening

Secondary Outcome Measures

Name	Time	Method
Adverse Events	10 years	All protocol defined adverse events as well as all-cause revision and/or removal of RAS

Trial Locations

Locations (1)

Regents of the University of Colorado; 🇺🇸 Denver, Colorado, United States