Evaluating outcomes after rotator cuff repair with a special implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects real-world data from patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant System. Conducted across up to 50 centers in the UK, Europe, and Australia, the study aims to evaluate patient outcomes following surgery. Up to 400 patients will be enrolled, and their progress will be monitored for up to two years post-surgery to assess the effectiveness of the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Melbourne Orthopaedic Group
  Windsor, Victoria, Australia Recruiting
• Schoen Klinik Lorsch
  Lorsch, Rhine, Germany Recruiting
• Schoen Klinik Dusseldorf
  Düsseldorf, Germany Recruiting
• Malteser Waldkrankenhaus Erlangen
  Erlangen, Germany Recruiting
• Sporthopaedie Heidelberg
  Heidelberg, Germany Recruiting
• St. Anna Hospital
  Herne, Germany Recruiting

Study contacts

• Study coordinator: Cat Whittall
• Email: catherine.whittall@smith-nephew.com
• Phone: +44 7841868997

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tracking recovery after arthroscopic shoulder and knee surgeries

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  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07501013

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.