Clinical Trial Finder

Restoration Anatomic Acetabular Shell Revision Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05591859
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stryker Orthopaedics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthropathy, Hip Arthropathy, Hip Osteoarthritis
Arms & Interventions

Arms

Other: Restoration Anatomic Acetabular Shell

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Regents of the University of Colorado, Denver, Colorado

Status

Recruiting

Address

Regents of the University of Colorado

Denver, Colorado, 80045

Site Contact

Frank Somoza

[email protected]

201-831-5000

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