Restoration Anatomic Acetabular Shell Revision Study (RAS)

Stryker

Status

Enrolling

Conditions

Hip Arthropathy

Hip Osteoarthritis

Arthropathy

Treatments

Device: Restoration Anatomic Acetabular Shell

Study type

Interventional

Funder types

Industry

Identifiers

NCT05591859

105

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.