Restoration Anatomic Acetabular Shell Revision Study

Hip Osteoarthritis Clinical Trial

— RAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591859
• Other study ID #: 105
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2024
• Est. completion date: March 1, 2036

Study information

• Verified date: November 2023
• Source: Stryker Orthopaedics
• Contact: Stryker JR Clinical Research
• Phone: 201-831-5000
• Email: StrykerJRClinical[@]stryker.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: March 1, 2036
• Est. primary completion date: March 1, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy
• Hip Arthropathy
• Hip Osteoarthritis
• Joint Diseases
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
United States	Regents of the University of Colorado	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Success rate is defined as no incidence of revision for aseptic loosening	10 years
Secondary	Adverse Events	All protocol defined adverse events as well as all-cause revision and/or removal of RAS	10 years