Restoration Anatomic Acetabular Shell Revision Study

Last updated: May 14, 2026
Sponsor: Stryker Orthopaedics
Overall Status: Trial Not Available

Phase

N/A

Condition

Arthritis And Arthritic Pain

Treatment

Restoration Anatomic Acetabular Shell

Clinical Study ID

NCT05591859
105
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is a candidate for a revision of a failed acetabular component with theRestoration 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 clinicalevaluations.

Exclusion

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 hipjoint at time of study device implantation.

  • Subject has a mental or neuromuscular disorder which would create an unacceptablerisk of prosthesis instability, prosthesis fixation failure, or complications inpostoperative care.

  • Subject has compromised bone stock which cannot provide adequate support and/orfixation to the prosthesis.

  • Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or ametabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

  • Subject is immunologically suppressed or receiving steroids in an excess of normalphysiological requirements (e.g. > 30 days).

  • Subject has a known sensitivity to device materials.

  • Subject is a prisoner.

Study Design

Treatment Group(s): 1
Primary Treatment: Restoration Anatomic Acetabular Shell
Phase:
Study Start date:
March 02, 2024
Estimated Completion Date:
March 01, 2036

Connect with a study center

  • Regents of the University of Colorado

    Denver, Colorado 80045
    United States

    Site Not Available

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