At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation (device)
- How long the study runs
- Study runs about 110 months (dates as stated)
- About the drug or intervention
- Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation — device: Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how well people recover after surgery to repair a rotator cuff tear in the shoulder, using a device called the REGENETEN Bioinductive Implant made by Smith & Nephew. The researchers will collect information from patients before and after their surgery. It is a registry study, which means it records real-world results from routine care.
Who can take part
- Adults aged over 18 who agree to take part and give their basic information before surgery
- People who are having keyhole surgery (arthroscopic rotator cuff repair) to fix a partial or full thickness tear in the rotator cuff of the shoulder
Who may not be able to
- People who, in the researcher's opinion, have an emotional or neurological condition that would make it hard or unwilling for them to take part, including mental illness, intellectual disability, or drug or alcohol misuse
- People for whom the REGENETEN device is not suitable, according to the maker's instructions for use
- People classed as 'vulnerable' under an international standard for medical device studies (ISO 14155:2020)
What taking part involves
- • Rotator cuff repair surgery done through small cuts using a camera (arthroscopic rotator cuff repair)
- • The REGENETEN Bioinductive Implant is used as part of the repair
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 400
- Started
- 2020-10-01
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for rotator cuff injuries
- • Clinical study - 400 participants
- • This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with rotator cuff injuries
Where?
- • Manchester - Manchester University NHS Foundation Trust
- • Harpenden - Spire Harpenden Hospital
- • Brighton - Spire Montefiore
- • Burnley - Burnley General Hospital
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.
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:
- ✓ Arthroscopic rotator cuff repair (ARCR)
What the study is looking for
- ✓Subject requires Arthroscopic rotator cuff repair (ARCR);
Who cannot take part
- ✗Subjects who do not meet the indication or are not safe to use according to specific Smith+Nephew REGENETEN System's...
- ✗Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
See the full criteria
Where Is This Study? (11 UK sites)
Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom
Spire Harpenden Hospital
Harpenden AL5 4BP, United Kingdom
Spire Montefiore
Brighton BN3 1RD, United Kingdom
Burnley General Hospital
Burnley BB10 2PQ, United Kingdom
Burnley General Teaching Hospital
Burnley BB10 2PQ, United Kingdom
Manchester University NHS Foundation Trust
Manchester M23 9LT, United Kingdom
Grantham and District Hospital
Grantham NG31 8DG, United Kingdom
University College London Hospitals
London NW1 2BU, United Kingdom
Cleveland Clinic London Hospital
London SW1X 7HY, United Kingdom
Sulis Hospital Bath
Bath BA2 8SF, United Kingdom
West Hertfordshire Hospitals NHS Trust
Hertford, United Kingdom
How to Get in Touch
Cat Whittall
Sponsor contactCONTACT
Tim Styche
Sponsor contactCONTACT