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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05591859
Other study ID # 105
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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