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NCT05591859 | RECRUITING | Arthropathy

Restoration Anatomic Acetabular Shell Revision Study
Sponsor:

Stryker Orthopaedics

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.

Condition or disease

Arthropathy

Hip Arthropathy

Hip Osteoarthritis

Intervention/treatment

Restoration Anatomic Acetabular Shell

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 56 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-03-02
Estimated Primary Completion Date : 2036-03-01
Estimated Study Completion Date : 2036-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Restoration Anatomic Acetabular Shell Revision Study

Location Details

NCT05591859

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Regents of the University of Colorado

Denver, Colorado, United States, 80045