NCT06857084 Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
| NCT ID | NCT06857084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Smith & Nephew, Inc. |
| Condition | Rotator Cuff Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2020-10-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Peter Lynch
STUDY DIRECTOR
Smith & Nephew, Inc.
Frequently Asked Questions
Who can join the NCT06857084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rotator Cuff Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06857084 currently recruiting?
Yes, NCT06857084 is actively recruiting participants. Contact the research team at catherine.whittall@smith-nephew.com for enrollment information.
Where is the NCT06857084 trial being conducted?
This trial is being conducted at Windsor, Australia, Lorsch, Germany, Düsseldorf, Germany, Erlangen, Germany and 11 additional locations.
Who is sponsoring the NCT06857084 clinical trial?
NCT06857084 is sponsored by Smith & Nephew, Inc.. The principal investigator is Peter Lynch at Smith & Nephew, Inc.. The trial plans to enroll 400 participants.