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NCT03339492 · ClinicalTrials.gov registry record · NA
PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears
A NA study, sponsored by Orthofix.
- Terminated
- Registry status
- NA
- Development phase
- 377
- Enrollment target
NCT03339492: Clinical Trial NA study, sponsored by Orthofix.
NCT03339492 is a NA study that was terminated before completion, run by Orthofix. The registered enrollment target is 377 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03339492, a NA study, was terminated before completion, sponsored by Orthofix.
- TERMINATED
- Registry status
- NA
- Development phase
- 377 participants
- Enrollment target
Study Summary
The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed electromagnetic fields (PEMF). The hypothesis states that exposure to a pulsed electromagnetic field (PEMF) following surgical repair of a full thickness rotator cuff tendon tear reduces tendon re-tear rates. The strength of the shoulder muscles and the levels of pain in subjects after surgical repair of their rotator cuff adjunctively treated with an active PEMF device will also be measured.
Primary Outcome
A reduction in retear rates in subjects adjunctively treated with PEMF compared with those treated with a placebo (inactive) RCStim PEMF device following surgical repair of full thickness rotator cuff tears.
Interventions
- DEVICE RCStim Model 1114
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
Why NCT03339492 stopped before completion
NCT03339492 is an interventional study that assigns participants to a tested intervention. The registered 377 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 (73% lower).
The record links to 0 conditions, and to 1 intervention - of which RCStim Model 1114 is the first listed.
NCT03339492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03339492 about?
NCT03339492 is a clinical study titled "PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears". The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed electromagnetic fields (PEMF). The hypothesis states that exposure to a pulse...
What is the current status of trial NCT03339492?
This trial is currently terminated. It is a NA study. The enrollment target is 377 participants. The study started on 2018-01-15. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03339492?
The interventions under investigation include: RCStim Model 1114 (DEVICE).
Who is sponsoring clinical trial NCT03339492?
This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03339492's enrollment target sits among peer trials
377 274th of 2000 higher than 1,727 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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