Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Germany, Italy, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry
Overview
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.
Interventions
- Device Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.
Primary outcome measures
- EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
- Quick DASH (Disabilities of Arm, Shoulder and Hand) Score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
- Oxford Shoulder Score (OSS) [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
- Pain, Visual Analog Scale (VAS) Score [Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months]
- Single Assessment Numeric Evaluation (SANE) Score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
Secondary outcome measures (3)
- Retear Rate [Time frame: 3 months, 6 months, 12 months, and 24 months]
- Post-operative Recovery: Sling Type and Mobilization Time [Time frame: 2 weeks]
- Post-operative Recovery: Return to Work [Time frame: Baseline and 6 months]
Eligibility criteria
Inclusion criteria
- Subject requires Arthroscopic rotator cuff repair (ARCR);
- Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.
Exclusion criteria
- Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.
- Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
- Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 11 centers
- Manchester University NHS Foundation Trust — Manchester
- Spire Harpenden Hospital — Harpenden
- Spire Montefiore — Brighton
- Burnley General Hospital — Burnley
- Burnley General Teaching Hospital — Burnley
- Manchester University NHS Foundation Trust — Manchester
- Grantham and District Hospital — Grantham
- University College London Hospitals — London
- … and 3 more centers
Germany · 7 centers
- Schoen Klinik Lorsch — Lorsch
- Schoen Klinik Dusseldorf — Düsseldorf
- Malteser Waldkrankenhaus Erlangen — Erlangen
- Sporthopaedie Heidelberg — Heidelberg
- St. Anna Hospital — Herne
- Artemed Klinikum München Süd — München
- OrthoMedicum Mittelhessen — Stadtallendorf
Italy · 3 centers
- Regional General Hospital F. Miulli — Acquaviva delle Fonti
- Ospedale Israelitico — Roma
- Ospedale di Sassuolo — Sassuolo
Australia · 1 center
- Melbourne Orthopaedic Group — Windsor
Identifiers
NCT: NCT06857084 · REGENETEN Global Registry