Clinical trial NCT06857084: Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry
Official title: Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Injuries
Keywords: Rotator Cuff Repair
Rotator Cuff Tear
Full Thickness Tear
Partial Thickness Tear
Massive Tear
REGENETEN Bioinductive Implant
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Smith & Nephew Asia Pacific Pte
First posted: 2025-03-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic Clinics/practices

Brief summary: 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.


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.

Primary outcomes:
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Oxford Shoulder Score (OSS)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Pain, Visual Analog Scale (VAS) Score
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcomes:
measure: Retear Rate
timeFrame: 3 months, 6 months, 12 months, and 24 months
measure: Post-operative Recovery: Sling Type and Mobilization Time
timeFrame: 2 weeks
measure: Post-operative Recovery: Return to Work
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Windsor
country: Australia
facility: Melbourne Orthopaedic Group
state: Victoria
city: Soissons
country: France
facility: Clinique Saint Christophe
state: Aisne
city: Lorsch
country: Germany
facility: Schoen Klinik Lorsch
state: Rhine
city: Düsseldorf
country: Germany
facility: Schoen Klinik Dusseldorf
city: Erlangen
country: Germany
facility: Malteser Waldkrankenhaus Erlangen
city: Heidelberg
country: Germany
facility: Sporthopaedie Heidelberg
city: Herne
country: Germany
facility: St. Anna Hospital
city: Stadtallendorf
country: Germany
facility: OrthoMedicum Mittelhessen
city: Acquaviva delle Fonti
country: Italy
facility: Regional General Hospital F. Miulli
state: Apulia
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
city: Harpenden
country: United Kingdom
facility: Spire Harpenden Hospital
state: Hertordshire
city: Brighton
country: United Kingdom
facility: Spire Montefiore
state: Hove
city: Burnley
country: United Kingdom
facility: Burnley General Hospital
state: Lancashire
city: Burnley
country: United Kingdom
facility: Burnley General Teaching Hospital
state: Lancashire
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Lancashire
city: Grantham
country: United Kingdom
facility: Grantham and District Hospital
state: Lincolnshire
city: Bath
country: United Kingdom
facility: Sulis Hospital Bath
state: Somerset
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Cleveland Clinic London Hospital
Study officials:
affiliation: Smith & Nephew, Inc.
name: Scott Reid
role: STUDY_DIRECTOR
References: