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PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears

NCT03339492 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2023-08-30

No results posted yet for this 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.

Conditions

  • Full-thickness Rotator Cuff Tear

Interventions

DEVICE

RCStim Model 1114

Active device emits PEMF signal; placebo/control device does not emit PEMF signal

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339492 on ClinicalTrials.gov