RECRUITING

Restoration Anatomic Acetabular Shell Revision Study

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Conditions

ArthropathyHip ArthropathyHip Osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-03-02
Study Completion:2036-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05591859

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
  2. * Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
  3. * Subject is skeletally mature.
  4. * Subject is a male or non-pregnant female.
  5. * Subject is willing and able to comply with postoperative scheduled clinical evaluations.
  1. * Subject has a non-Stryker retained stem at the time of study device implantation.
  2. * Subject has a Body Mass Index (BMI) \> 45.
  3. * Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
  4. * Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  5. * Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
  6. * 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.
  7. * Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days).
  8. * Subject has a known sensitivity to device materials.
  9. * Subject is a prisoner.

Contacts and Locations

Study Contact

Sabrina Cristofaro
CONTACT
5513298665
sabrina.cristofaro@stryker.com
Marissa Puccio
CONTACT
2016751416
marissa.puccio@stryker.com

Study Locations (Sites)

Regents of the University of Colorado
Denver, Colorado, 80045
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-03-02
Study Completion Date2036-03-01

Study Record Updates

Study Start Date2024-03-02
Study Completion Date2036-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Arthropathy
  • Hip Arthropathy
  • Hip Osteoarthritis