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Orthopedic Implant
Acetabular Shell Revision for Hip Arthritis (RAS Trial)
N/A
Recruiting
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
RAS Trial Summary
This trial studies the success of hip replacement from previously failed total hip replacements in consecutive patients who meet the criteria.
Who is the study for?
This trial is for individuals needing a revision of a failed hip replacement component, specifically with the Restoration Anatomic Acetabular Shell. Participants must be adults who can follow post-op check-ups and have signed an informed consent form. Those with extreme obesity (BMI > 45), infections around the hip, immune suppression, mental or neuromuscular issues affecting recovery, poor bone quality, or sensitivity to device materials cannot join.Check my eligibility
What is being tested?
The study is testing the long-term effectiveness ('survivorship') of the RAS acetabular shell in patients whose previous total hip arthroplasty has failed. It's a non-randomized study tracking patients both retrospectively and prospectively after they receive this specific implant.See study design
What are the potential side effects?
While not explicitly listed in your information provided, typical side effects from similar procedures may include pain at the implant site, infection risks, possible dislocation or instability of the new component, allergic reactions to material if present before exclusion.
RAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success rate
Secondary outcome measures
Adverse Events
RAS Trial Design
1Treatment groups
Experimental Treatment
Group I: Restoration Anatomic Acetabular ShellExperimental Treatment1 Intervention
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Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,377 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like Lupus or Paget's Disease affecting my bones.I am on long-term steroids or have a weakened immune system.I am a man or a woman not currently pregnant.I am a candidate for hip socket revision surgery.I might have an infection in or near my hip where a device will be implanted.My bones are too weak to support or attach to a prosthesis properly.My bones have stopped growing.
Research Study Groups:
This trial has the following groups:- Group 1: Restoration Anatomic Acetabular Shell
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for test subjects in this experiment?
"According to the most recent update on clinicaltrials.gov, this particular trial is no longer recruiting patients. Although this study has already completed its recruitment goal, there are still 235 other medical studies that are currently looking for participants."
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