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NCT03734536 · ClinicalTrials.gov registry record · NA

Treatment of Partial-Thickness Rotator Cuff Tears

A NA study, sponsored by Smith & Nephew.

Terminated
Registry status
NA
Development phase
168
Enrollment target

NCT03734536: Clinical Trial NA study, sponsored by Smith & Nephew.

NCT03734536 is a NA study that was terminated before completion, run by Smith & Nephew. The registered enrollment target is 168 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03734536, a NA study, was terminated before completion, sponsored by Smith & Nephew.

TERMINATED
Registry status
NA
Development phase
168 participants
Enrollment target

Study Summary

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

Primary Outcome

American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

Interventions

  • DEVICE REGENETEN™ Bioinductive Implant
  • DEVICE Arthroscopic repair of the high-grade (>50%) partial-thickness

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2018-12-05
Est. Completion 2023-09-11
Phase NA
Smith & Nephew

72 total trials

Why NCT03734536 stopped before completion

NCT03734536 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which REGENETEN™ Bioinductive Implant is the first listed.

NCT03734536 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03734536 about?

NCT03734536 is a clinical study titled "Treatment of Partial-Thickness Rotator Cuff Tears". The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

What is the current status of trial NCT03734536?

This trial is currently terminated. It is a NA study. The enrollment target is 168 participants. The study started on 2018-12-05. Estimated completion is 2023-09-11.

What interventions are being tested in trial NCT03734536?

The interventions under investigation include: REGENETEN™ Bioinductive Implant (DEVICE), Arthroscopic repair of the high-grade (>50%) partial-thickness (DEVICE).

Who is sponsoring clinical trial NCT03734536?

This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03734536's enrollment target sits among peer trials

168 619th of 2000 higher than 1,379 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03734536, the US trial registry maintained by the National Library of Medicine. NCT03734536 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.