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Bioinductive Implant
Bioinductive Implant for Rotator Cuff Tears (IMPACT Trial)
N/A
Recruiting
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus
Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3 and 6 weeks, 3, 6, 12 and 24 months
Awards & highlights
IMPACT Trial Summary
This trial will test whether a new tendon repair surgery is better than the standard repair surgery.
Who is the study for?
This trial is for adults over 18 with high-grade partial-thickness rotator cuff tears who haven't improved after 3 months of non-surgical treatment. Candidates must be able to attend all study visits and complete questionnaires. Exclusions include prior shoulder surgery, full thickness tears, certain joint conditions, pregnancy, litigation or compensation claims related to the shoulder injury, drug/alcohol abuse, hypersensitivity to bovine materials, and inability to undergo MRI.Check my eligibility
What is being tested?
The study compares the REGENETEN™ Bioinductive Implant with standard 'Completion and Repair' technique in treating partial-thickness rotator cuff tears. It aims to determine if patients can return faster to daily activities using the implant versus traditional repair methods.See study design
What are the potential side effects?
Potential side effects may include reactions at the surgery site due to sensitivity towards bovine-derived materials used in the implant system. Other general risks involve complications from surgical procedures such as infection or issues related to anesthesia.
IMPACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a severe tear in my shoulder tendon.
Select...
I have tried non-surgical treatments for my shoulder tear for at least 3 months without success.
IMPACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3 and 6 weeks, 3, 6, 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3 and 6 weeks, 3, 6, 12 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Constant-Murley Score
Change in Subjective Shoulder Value (SSV) score
Change in Western Ontario Rotator Cuff (WORC)
+22 moreIMPACT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Isolated Bioinductive RepairExperimental Treatment1 Intervention
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Group II: Completion and RepairActive Control1 Intervention
Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
Find a Location
Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
165 Previous Clinical Trials
22,325 Total Patients Enrolled
Laura MillsStudy ChairSmith & Nephew, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a nerve condition affecting my arms.I am older than 18 years.I can attend all required study visits.My osteoarthritis is grade 2 or higher according to Samilson-Prieto.I have a complete tear in my shoulder's rotator cuff.I have had surgery on my shoulder, including procedures like subacromial decompression or biceps tenodesis.I need surgery for a tear in my shoulder muscle.I need surgery for my biceps tendon.I need surgery to fix a shoulder bone anomaly.I need surgery for a shoulder injury, including labral or bone repair.I do not have severe shoulder damage or conditions that would interfere with a specific shoulder repair procedure.You have an allergy to materials derived from cows.I have had an infection in the same shoulder before.I have tried non-surgical treatments for my shoulder tear for at least 3 months without success.I haven't taken any steroids or had steroid injections in the last 3 months.I can follow instructions and fill out all study forms.I have a severe tear in my shoulder tendon.I have tried non-surgical treatments for my shoulder tear for at least 3 months without success.I am scheduled for surgery on the opposite shoulder during the study.My shoulder joint has dislocated multiple times.You cannot have an MRI scan because of mental health or medical reasons.I have a history of joint inflammation or chronic pain in my arms or shoulders.My tendon injury cannot be managed with the REGENETEN implant due to poor tissue quality.
Research Study Groups:
This trial has the following groups:- Group 1: Isolated Bioinductive Repair
- Group 2: Completion and Repair
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.
Rotator Cuff Injury Patient Testimony for trial: Trial Name: NCT05444465 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current scope of participants in this experiment?
"To successfully execute this trial, 156 patients who satisfy the study's criteria must participate. Smith & Nephew, Inc., is managing the experiment across multiple sites including Research St. Joseph's in Hamilton, Ontario and Harbin Clinic in Rome, Georgia."
Answered by AI
Are patient enrollments still active for this research project?
"Clinicaltrials.gov reports that this research study is actively looking for candidates, which was first posted on August 30th 2022 and most recently updated on October 11th 2022."
Answered by AI
Are there any US-based research facilities carrying out this clinical experiment?
"Patients interested in this trial have the option to register at Research St. Joseph's of Hamilton, Ontario; Harbin Clinic in Rome, Georgia; Texas Orthopedic Specialists located in Bedford, TX and 3 other locations."
Answered by AI
Who else is applying?
What state do they live in?
District of Columbia
California
Other
Maryland
What site did they apply to?
Sinai Hospital Baltimore
Houston Methodist The Woodlands
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've been living with this Rotator cuff injury for over 10+ years and it's not getting any better, without some kind of surgery it won't ever get better.
PatientReceived 1 prior treatment
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