Actively Recruiting
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry
Led by Smith & Nephew, Inc. · Updated on 2025-03-04
400
Participants Needed
19
Research Sites
378 weeks
Total Duration
On this page
Sponsors
S
Smith & Nephew, Inc.
Lead Sponsor
S
Smith & Nephew Asia Pacific Pte
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Requires arthroscopic rotator cuff repair
- Aged over 18 years at time of consent
- Provides baseline data before rotator cuff repair surgery (partial or full thickness tears)
You will not qualify if you...
- Has emotional or neurological conditions affecting participation, including mental illness, intellectual disability, or drug/alcohol abuse
- Does not meet the device's Instructions for Use or is contraindicated for the REGENETEN System
- Considered a vulnerable subject as defined by ISO14155:2020 Section 3.44
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Melbourne Orthopaedic Group
Windsor, Victoria, Australia, 3181
Not Yet Recruiting
2
Clinique Saint Christophe
Soissons, Aisne, France, 02200
Not Yet Recruiting
3
Schoen Klinik Lorsch
Lorsch, Rhine, Germany, 64653
Not Yet Recruiting
4
Schoen Klinik Dusseldorf
Düsseldorf, Germany, 40549
Not Yet Recruiting
5
Malteser Waldkrankenhaus Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
6
Sporthopaedie Heidelberg
Heidelberg, Germany, 69121
Not Yet Recruiting
7
St. Anna Hospital
Herne, Germany, 44649
Not Yet Recruiting
8
OrthoMedicum Mittelhessen
Stadtallendorf, Germany, 35260
Not Yet Recruiting
9
Regional General Hospital F. Miulli
Acquaviva delle Fonti, Apulia, Italy, 70021
Not Yet Recruiting
10
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
11
Spire Harpenden Hospital
Harpenden, Hertordshire, United Kingdom, AL5 4BP
Actively Recruiting
12
Spire Montefiore
Brighton, Hove, United Kingdom, BN3 1RD
Actively Recruiting
13
Burnley General Hospital
Burnley, Lancashire, United Kingdom, BB10 2PQ
Actively Recruiting
14
Burnley General Teaching Hospital
Burnley, Lancashire, United Kingdom, BB10 2PQ
Actively Recruiting
15
Manchester University NHS Foundation Trust
Manchester, Lancashire, United Kingdom, M23 9LT
Actively Recruiting
16
Grantham and District Hospital
Grantham, Lincolnshire, United Kingdom, NG31 8DG
Actively Recruiting
17
University College London Hospitals
London, London, United Kingdom, NW1 2BU
Actively Recruiting
18
Cleveland Clinic London Hospital
London, London, United Kingdom, SW1X 7HY
Actively Recruiting
19
Sulis Hospital Bath
Bath, Somerset, United Kingdom, BA2 8SF
Actively Recruiting
Research Team
S
Sarah Turner
CONTACT
T
Tim Styche
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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