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Bioinductive Implant
REGENETEN™ Bioinductive Implant for Arthroscopic Surgical Treatment of Partial-thickness Tears (REGEN PUB 2018 Trial)
N/A
Waitlist Available
Led By Howard Harris
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months following index surgery
Awards & highlights
REGEN PUB 2018 Trial Summary
This trial demonstrates that REGENETEN is a more effective treatment than standard repair techniques for high-grade partial-thickness tears, as it preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery.
Eligible Conditions
- Arthroscopic Surgical Treatment of High-grade Partial-thickness Tears
REGEN PUB 2018 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months following index surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months following index surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ASES (American Shoulder and Elbow Surgeons) score tear using standard surgical techniques.
Secondary outcome measures
ASES VAS pain score
ASES Visual Analog Scale (VAS) pain score
ASES score
+14 moreREGEN PUB 2018 Trial Design
2Treatment groups
Experimental Treatment
Group I: REGENETEN™ Bioinductive ImplantExperimental Treatment1 Intervention
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Group II: Arthroscopic repair of the high-grade (>50%) partialthicknessExperimental Treatment1 Intervention
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
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Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
165 Previous Clinical Trials
22,363 Total Patients Enrolled
Global Research SolutionsIndustry Sponsor
4 Previous Clinical Trials
1,175 Total Patients Enrolled
Medical Metrics Diagnostics, IncIndustry Sponsor
12 Previous Clinical Trials
1,587 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been taking steroids within the past month.You have a long-term pain condition like fibromyalgia.You have smoked heavily, more than one pack of cigarettes per day, within the past six months.You are allergic to materials that come from cows.You have recently undergone surgery to repair your biceps tendon.You have received four to six weeks of formal physical therapy or have been doing exercises at home with guidance.You had a previous surgery on your shoulder for a rotator cuff injury, but it did not successfully fix the problem.You recently had surgery to repair a bone defect or a tear in your shoulder.You have a history of needing insulin to manage your diabetes.You have severe osteoarthritis.You have tried other non-surgical treatments for your tendon tear, but they didn't work.The surgeon may decide to give you a shoulder injection if they think it's necessary.
Research Study Groups:
This trial has the following groups:- Group 1: REGENETEN™ Bioinductive Implant
- Group 2: Arthroscopic repair of the high-grade (>50%) partialthickness
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.
Is enrollment available for this research trial?
"This trial, initially posted on December 3rd 2018 and last edited May 23rd 2022, is not actively searching for new patients. However, there are over one hundred other studies currently welcoming participants into their trials."
Answered by AI
How many locations in the state are currently hosting this research project?
"This trial is enrolling patients at 10 distinct sites across the United States, including University of Florida Orthopaedics and Sports Medicine in Gainesville, University of Kentucky in Lexington, Baptist Health in Jacksonville Beach, and other centres."
Answered by AI
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