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Orthopedic Implant
REDAPT Sleeved Stem for Hip Replacement Safety and Performance Evaluation
N/A
Waitlist Available
Research Sponsored by Foundation for Orthopaedic Research and Education
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 2 year
Awards & highlights
Study Summary
This trial looks at outcomes of a hip replacement procedure over 2 years, to see if it's effective in improving quality of life.
Who is the study for?
This trial is for adults with certain hip conditions needing surgery, like rheumatoid arthritis, hip fractures, or degenerative diseases such as osteoarthritis. It's not suitable for those with poor bone quality, infections that could affect the implant, mental conditions affecting recovery cooperation, or individuals who are not fully grown.Check my eligibility
What is being tested?
The study is evaluating the safety and performance of a specific hip implant called REDAPT Sleeved Stem over two years. It includes both looking back at past patients (retrospective) and tracking current ones going forward (prospective).See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the site of surgery, infection risk from the procedure itself or the implant, possible damage to surrounding tissues or nerves during operation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HOOS Jr.
Harris HIp Score (HHS)
Hip Disablity and Osterarthritis Outcome Score (HOOS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: single armExperimental Treatment1 Intervention
subjects who have redapt sleeved stem implant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REDAPT Sleeved Stem
2022
N/A
~50
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Who is running the clinical trial?
Foundation for Orthopaedic Research and EducationLead Sponsor
13 Previous Clinical Trials
1,037 Total Patients Enrolled
Smith & Nephew, Inc.Industry Sponsor
165 Previous Clinical Trials
22,436 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My bones are still growing.I have a hip condition such as rheumatoid arthritis or a specific type of fracture.I don't have conditions like poor blood supply, weak bones, or infections that would prevent successful implant surgery.I need surgery for my hip due to arthritis or injury.
Research Study Groups:
This trial has the following groups:- Group 1: single arm
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.
Do any vacancies remain for participants in this experiment?
"Clinicaltrials.gov reports that this study is not actively searching for participants, despite being initially posted on November 1st 2022 and last updated October 31st 2022. Nevertheless, there are other trials in the same field currently enrolling patients."
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