Restoration Anatomic Acetabular Shell Revision Study

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.

Conditions

Arthropathy, Hip Arthropathy, Hip Osteoarthritis

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Study Overview

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Study Details

Study overview

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.

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

Restoration Anatomic Acetabular Shell Revision Study

Condition
Arthropathy
Intervention / Treatment

-

Contacts and Locations

Denver

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stryker Orthopaedics,

Study Record Dates

2036-03-01