Restoration Anatomic Acetabular Shell Revision Study
RAS
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
March 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2036
October 24, 2025
October 1, 2025
12 years
October 19, 2022
October 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate
Success rate is defined as no incidence of revision for aseptic loosening
10 years
Secondary Outcomes (1)
Adverse Events
10 years
Study Arms (1)
Restoration Anatomic Acetabular Shell
OTHERInterventions
Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regents of the University of Colorado
Denver, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2022
First Posted
October 24, 2022
Study Start
March 2, 2024
Primary Completion (Estimated)
March 1, 2036
Study Completion (Estimated)
March 1, 2036
Last Updated
October 24, 2025
Record last verified: 2025-10