Restoration Anatomic Acetabular Shell Revision Study (RAS)

March 20, 2024 updated by: Stryker Orthopaedics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • Recruiting
        • Regents of the University of Colorado
        • Contact:
        • Principal Investigator:
          • Craig Hogan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Restoration Anatomic Acetabular Shell
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 10 years
Success rate is defined as no incidence of revision for aseptic loosening
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 10 years
All protocol defined adverse events as well as all-cause revision and/or removal of RAS
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2024

Primary Completion (Estimated)

March 1, 2036

Study Completion (Estimated)

March 1, 2036

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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