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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Full-thickness Rotator Cuff Tear

In brief

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.

Key facts

Study ID: NCT03339492
Run by: Orthofix Inc.
People needed: 377
Starts: 2018-01-15
Expected to finish: 2022-12-31
Last updated by the study team: 2023-08-30

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject may be male or female between 21 years of age and 80 years of age at the time of consent.
Subject must have a repairable (≥1 and ≤ 5 cm in the AP direction) full thickness tear of either the supraspinatus tendon or both the supraspinatus and infraspinatus tendons, as determined by MRI and confirmed intra-operatively (pre-debridement) during the surgical repair of the rotator cuff using a calibrated probe.
a. Subjects who do not meet this criterion will be considered screen failures.
This must be the first rotator cuff repair surgery on the study shoulder with the following exceptions:
Previous repairs of the teres minor and/or the subscapularis muscles are permitted.
Previous acromioplasties, decompressions, and clavicular fracture repairs are permitted.
Concurrent acromioplasties, subacromial decompressions and/or distal clavicular excisions are permitted.
Concurrent fracture repairs or reconstructions are NOT permitted.
Biceps tenodesis or tenotomy (open or closed) are permitted.
Subject must not have used NSAIDs for one (1) week prior to surgery.
Subjects must agree NOT to use NSAIDS suring the first 6 weeks of the study. Low dose aspirin (81 mg) is permitted.
Subject must be willing and able to participate in post-operative physical therapy exercises.
Subject must be willing and able to follow all study procedures and return for all study visits.
Subject must have reliable access to any iOS device using iOS v.9.3 or later or an Android device with WiFi access for downloading the free device-specific app.
Subject must understand and be willing to sign the IRB-approved Informed Consent Document.

You may not qualify if…

Subject has a tear <1cm or >5cm in size measured intraoperatively, pre-debridement, using a calibrated probe.
a. Subjects who do not meet this criterion will be considered screen failures.
Subject has a BMI > 45.
Subject has a pacemaker or defibrillator.
Subject is not able to or is unwilling to have an MRI on the study shoulder.
Subject requires assistive devices to walk such as crutches or walkers.
Subject has a rotator cuff tear in which the subscpularis tendon requires repair.
a. Biceps tenodesis or tenotomy (open or closed) is allowed.
Subject has a Fuchs score grade of 3 for fatty infiltration on any of the rotator cuff muscles.
Grade 1: Normal muscle, no or some fatty streaks Grade 2: Moderately pathologic muscle; more muscle than fat Grade 3: Advanced degeneration; as much muscle as fat or less muscle than fat
Subject has moderate to severe arthritis based on preoperative imaging or as judged at the time of arthroscopy.
Pre-operative x-ray findings consistent with Grade 3 or Grade 4 glenohumeral arthritis, where the grades are defined as follows:
Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2: definite osteophytes and definite narrowing of joint space; Grade 3: moderate multiple osteophytes and definite narrowing of joint space and some sclerosis and possible deformity of bone contour.
Grade 4: bone on bone morphology
Intra-operative exposed subchondral bone involving >= 50% of either the humeral head, glenoid or both.
Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
Subject has a known inflammatory or autoimmune connective tissue disease such as, but not limited to, gout affecting the shoulder, scleroderma, SLE, rheumatoid disease, or calcific tendonitis of the shoulder.
Subject has a metabolic bone disease such as Paget's disease or osteomalacia.
a. Subjects with osteoporosis are not excluded from the study.
Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
Subject has HIV, hepatitis, or has had an active malignancy in the past 5 years.
Subject has had previous rotator cuff repairs or repairs of the labrum.
a. See Inclusion Criterion #3 for permitted surgeries.
Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
Subject has shoulder pain of unknown etiology.

Where it is running

The CORE Institute — Phoenix, Arizona, United States
Stanford University — Redwood City, California, United States
UCSF Orthopedics — San Francisco, California, United States
Sabesan Orthopedics Research — Atlantis, Florida, United States
Coastal Orthopedics and Sports Medicine — Bradenton, Florida, United States
Holy Cross Hospital — Fort Lauderdale, Florida, United States
Andrews Institute — Gulf Breeze, Florida, United States
Cleveland Clinic Florida — Weston, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
Univ. of Maryland Dept of Orthopedics — Baltimore, Maryland, United States
Sinai Hospital of Baltimore — Baltimore, Maryland, United States
Univ of Michigan Orthopedic Sports Medicine Program — Ann Arbor, Michigan, United States
Univ Orthopedics Associates at Great Neck — Great Neck, New York, United States
Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
Cincinnati Sports Medicine — Cincinnati, Ohio, United States
Univ. of Pennsylvania Orthopedics — Philadelphia, Pennsylvania, United States
The Rothman Institute — Philadelphia, Pennsylvania, United States
University Orthopedics Center — State College, Pennsylvania, United States
South Carolina Sports Medicine and Orthopedics — North Charleston, South Carolina, United States
The Campbell Clinic — Germantown, Tennessee, United States
Deutsch Shoulder — Houston, Texas, United States
Atlantic Orthopedics — Virginia Beach, Virginia, United States
Jordan-Young Research Institute — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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