Actively Recruiting
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
Led by Smith & Nephew, Inc. · Updated on 2026-01-15
234
Participants Needed
20
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
CONDITIONS
Official Title
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be older than 18 years
- Have an isolated high-grade (>50% or >6mm) partial thickness tear of the supraspinatus or supraspinatus with infraspinatus
- Have failed at least 3 months of conservative treatment for partial thickness rotator cuff tear
- Be willing and able to attend all required study visits
- Be able to follow instructions and complete all study questionnaires
You will not qualify if you...
- Have insufficient tendon tissue quality for treatment with the REGENETEN Bioinductive Implant system
- Have physical therapy needs not suitable for the study's rehabilitation guidelines
- Have Samilson-Prieto osteoarthritis grade 2 or higher
- Have current or prior infection in the affected shoulder
- Have known allergy to bovine-derived materials
- Have inflammatory arthropathy or chronic joint disease or chronic pain in upper extremities
- Have had prior surgery on the affected shoulder including specific procedures like subacromial decompression or biceps tenodesis
- Have planned surgery on the opposite shoulder during the study period
- Have used systemic or local steroids within 3 months before surgery
- Have a full thickness rotator cuff tear
- Have a subscapularis tear requiring repair
- Require additional surgeries like labral fixation, bone implantation, SLAP repair, or os acromiale fixation
- Have glenohumeral joint instability
- Have conditions complicating outcomes such as advanced rotator cuff arthropathy, severe muscle atrophy, fractures, or avascular necrosis
- Have neurological conditions affecting upper extremities
- Be unable to tolerate MRI due to medical or psychiatric reasons
- Be pregnant or breastfeeding
- Be involved in injury litigation related to the affected shoulder
- Have a current workers compensation claim
- Be enrolled or planning to enroll in another clinical trial affecting outcomes
- Have a history of poor compliance with medical treatment, physical therapy, or study participation
- Have emotional or neurological conditions affecting participation ability
- Not meet the REGENETEN System's instructions for use
- Be classified as a vulnerable subject per ISO standards
- Have participated previously in this trial
- Have medical or physical conditions precluding safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Harbin Clinic
Rome, Georgia, United States, 30165
Actively Recruiting
2
OrthoIllinois LTD
Rockford, Illinois, United States, 61107
Actively Recruiting
3
Sinai Hospital Baltimore
Baltimore, Maryland, United States, 21215
Withdrawn
4
Cleveland Clinic - Sports Health
Garfield Heights, Ohio, United States, 44125
Withdrawn
5
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
6
Texas Orthopedic Specialists
Bedford, Texas, United States, 76021
Actively Recruiting
7
Houston Methodist The Woodlands
The Woodlands, Texas, United States, 77385
Withdrawn
8
Memorial Medical Center
Ashland, Wisconsin, United States, 54806
Withdrawn
9
OrthoSport Victoria
Richmond, Victoria, Australia, 3121
Actively Recruiting
10
Access Orthopaedics
Calgary, Alberta, Canada, T2R 2G5
Actively Recruiting
11
Pan Am Clinic
Winnipeg, Manitoba, Canada
Actively Recruiting
12
Research St. Joseph's
Hamilton, Ontario, Canada
Actively Recruiting
13
IRCCS Istituto Ortopedico Galeazzi,
Milan, Italy
Actively Recruiting
14
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Actively Recruiting
15
Hospital Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
16
Hospital Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
17
Ashford & St Peter's Hospitals NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ
Actively Recruiting
18
Sulis Hospital
Bath, United Kingdom
Actively Recruiting
19
North Bristol NHS Trust
Bristol, United Kingdom
Actively Recruiting
20
Northern Care Alliance NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Withdrawn
Research Team
A
Alice Kitching
CONTACT
M
Mary Ozokwere
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here