Actively Recruiting

Phase Not Applicable
All Genders
NCT05591859

Restoration Anatomic Acetabular Shell Revision Study

Led by Stryker Orthopaedics · Updated on 2025-10-24

56

Participants Needed

1

Research Sites

626 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Restoration Anatomic Acetabular Shell Revision Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Candidate for revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell
  • Signed IRB-approved, study specific Informed Consent Form
  • Skeletally mature
  • Male or non-pregnant female
  • Willing and able to comply with postoperative scheduled clinical evaluations
Not Eligible

You will not qualify if you...

  • Non-Stryker retained stem at time of study device implantation
  • Body Mass Index (BMI) greater than 45
  • Active or suspected latent infection in or around the affected hip joint at implantation
  • Mental or neuromuscular disorder creating unacceptable risk of implant instability or complications
  • Compromised bone stock unable to support or fix the prosthesis
  • Diagnosed with systemic or metabolic diseases causing progressive bone deterioration
  • Immunologically suppressed or receiving steroids beyond normal physiological levels for more than 30 days
  • Known sensitivity to device materials
  • Prisoner

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Regents of the University of Colorado

Denver, Colorado, United States, 80045

Actively Recruiting

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Research Team

S

Sabrina Cristofaro

CONTACT

M

Marissa Puccio

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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