At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Isolated Bioinductive Repair (device), Completion and Repair (procedure)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- Isolated Bioinductive Repair — device: Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant · Completion and Repair — procedure: Standard surgical repair using the 'Completion and Repair' technique.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 234
- Started
- 2022-08-30
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for rotator cuff injuries
- • NA - 234 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with rotator cuff injuries
Where?
- • Chertsey - Ashford & St Peter's Hospitals NHS Foundation Trust
- • Bath - Sulis Hospital
- • Bristol - North Bristol NHS Trust
- • Salford - Northern Care Alliance NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ study visits
What the study is looking for
- ✓The subject must provide written agreement to take part.
- ✓Subject is \> eighteen (18) years of age (no upper limit).
- ✓Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or...
- ✓Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff...
- ✓Subject willing and able to make all required study visits.
Who cannot take part
- ✗Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the...
- ✗Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their...
- ✗Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
- ✗Subjects with current or prior infection of the ipsilateral shoulder.
- ✗Subjects with known hypersensitivity to bovine-derived materials.
See the full criteria
Where Is This Study? (4 UK sites)
Ashford & St Peter's Hospitals NHS Foundation Trust
Chertsey KT16 0PZ, United Kingdom
Sulis Hospital
Bath, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Northern Care Alliance NHS Foundation Trust
Salford M6 8HD, United Kingdom
How to Get in Touch
Judith Horner
Sponsor contactCONTACT
Mary Ozokwere
Sponsor contactCONTACT
