RecruitingNot Applicable

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry

Australia, France, Germany400 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Quick DASH (Disabilities of Arm, Shoulder and Hand) Score

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Oxford Shoulder Score (OSS)

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Pain, Visual Analog Scale (VAS) Score

Timeframe: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months

Single Assessment Numeric Evaluation (SANE) Score

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Trial details

NCT IDNCT06857084

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Sarah Turner

+44 7583 029252 Sarah.Turner@smith-nephew.com

View on ClinicalTrials.gov More Rotator Cuff Injuries trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Quick DASH (Disabilities of Arm, Shoulder and Hand) Score

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Oxford Shoulder Score (OSS)

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Pain, Visual Analog Scale (VAS) Score

Timeframe: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months

Single Assessment Numeric Evaluation (SANE) Score

Timeframe: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months