Arthropathy, Hip Arthropathy, Hip Osteoarthritis
Conditions
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.
Interventions
DEVICERestoration 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.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 10 years | Success rate is defined as no incidence of revision for aseptic loosening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 10 years | All protocol defined adverse events as well as all-cause revision and/or removal of RAS |
Countries
United States
Outcome results
None listed