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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 is a NA study that was terminated before completion, run by Orthofix. The registered enrollment target is 377 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03339492
The ClinicalTrials.gov registry entry for NCT03339492 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 377 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orthofix, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RCStim Model 1114 is the first listed.
NCT03339492 reports 0 study locations.
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.
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