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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant

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NCT06857084 · readout in 1,230 d

Sponsored by Smith & Nephew, Inc. (industry) · SNN — their whole pipeline →.

Phase
Status
Recruiting
Study type
Observational
Enrollment
400estimated
Sites
22
Countries
Australia, Germany, Italy +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-10-01actualWhen the study began enrolling
Primary completion2029-12-31estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-12-31estimatedThe whole study's end, after follow-up
First posted2025-03-04actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-01actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Rotator Cuff Injuries

Intervention

  • Device: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

Primary outcomes

what the primary-completion date above is the date OF
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
measured Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
measured Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Oxford Shoulder Score (OSS)
measured Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Pain, Visual Analog Scale (VAS) Score
measured Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
Single Assessment Numeric Evaluation (SANE) Score
measured Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

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