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Terminated Not applicable Interventional

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

ClinicalTrials.gov ID: NCT03339492

Public ClinicalTrials.gov record NCT03339492. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 4:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy as an Adjunctive Treatment to Surgical Repair of Full Thickness Rotator Cuff Tears

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03339492
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
Orthofix Inc.
Industry
Enrollment
377 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
21 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 15, 2018 (Actual)
Primary completion
Dec 31, 2022 (Actual)
Completion
Dec 31, 2022 (Actual)
Last update posted
Aug 30, 2023

2018 – 2022

United States locations

U.S. sites
23
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
The CORE Institute Phoenix Arizona 85023 —
Stanford University Redwood City California 94063 —
UCSF Orthopedics San Francisco California 94158 —
Sabesan Orthopedics Research Atlantis Florida 33462 —
Coastal Orthopedics and Sports Medicine Bradenton Florida 34209 —
Holy Cross Hospital Fort Lauderdale Florida 33334 —
Andrews Institute Gulf Breeze Florida 32561 —
Cleveland Clinic Florida Weston Florida 33331 —
Rush University Medical Center Chicago Illinois 60612 —
Univ. of Maryland Dept of Orthopedics Baltimore Maryland 21201 —
Sinai Hospital of Baltimore Baltimore Maryland 21215 —
Univ of Michigan Orthopedic Sports Medicine Program Ann Arbor Michigan 48106 —
Univ Orthopedics Associates at Great Neck Great Neck New York 11021 —
Wake Forest Baptist Health Winston-Salem North Carolina 27157 —
Cincinnati Sports Medicine Cincinnati Ohio 45242 —
Univ. of Pennsylvania Orthopedics Philadelphia Pennsylvania 19104 —
The Rothman Institute Philadelphia Pennsylvania 19107 —
University Orthopedics Center State College Pennsylvania 16801 —
South Carolina Sports Medicine and Orthopedics North Charleston South Carolina 29406 —
The Campbell Clinic Germantown Tennessee 38138 —
Deutsch Shoulder Houston Texas 77401 —
Atlantic Orthopedics Virginia Beach Virginia 23456 —
Jordan-Young Research Institute Virginia Beach Virginia 23462 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03339492, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 30, 2023 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03339492 live on ClinicalTrials.gov.

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