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

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ClinicalTrials.gov Identifier: NCT03339492
Recruitment Status : Enrolling by invitation
First Posted : November 13, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Full-thickness Rotator Cuff Tear Device: RCStim Model 1114 Not Applicable

Detailed Description:

This Clinical Investigation Plan (CIP) describes the 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.

Rotator cuff tears are common musculoskeletal injuries which often require surgical intervention. Unfortunately, post-repair prognosis is poor, and surgical repairs have been reported to fail in up to 94% of cases (Galatz et. al., 2004). Repaired tissue tends to be fibrotic, disorganized, and reattaches poorly to the bony insertion. To improve tendon-to-bone healing, many non-invasive therapeutic devices have been utilized post-operatively including therapeutic ultrasound and shock wave therapy (Lovric et. al., 2013; Springer and Badgett, 2015).

In orthopedics, the use of these non-invasive therapeutic devices has become increasingly popular during the post-operative recovery period in an effort to enhance tissue healing. These devices are relatively inexpensive and easily obtainable and relatively easy to use, and are especially enticing as they can be brought into the patient's home and do not require frequent visits to the clinic. Additionally, non-invasive therapeutic devices can be used for a variety of applications, including promoting tissue healing prior to surgical intervention or in lieu of surgical intervention all together. Although there are numerous advantages to using non-invasive therapeutic devices, their efficacy has not yet been maximized.

Based on the pre-clinical work presented (Tucker et. al., 2016; Huegel et. al., 2017), it is believed that pulsed electromagnetic fields may be an effective adjunctive treatment for patients who have undergone surgical repair of a torn rotator cuff.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active PEMF
Subjects have 2 out of 3 chance to get the active device which emits a pulsed electromagnetic field (PEMF) from the RCStim Model 1114 device (right and left side models available). Double-blind randomization.
Device: RCStim Model 1114
Active device emits PEMF signal; placebo/control device does not emit PEMF signal
Other Name: Orthofix rotator cuff soft tissue stimulator

Sham Comparator: Control/placebo PEMF
Subjects have a 1 out of 3 chance to get the control/placebo device which does not emit a pulsed electromagnetic field (PEMF) from the RCStim Model 1114 device (right and left side models available). Double-blind randomization.
Device: RCStim Model 1114
Active device emits PEMF signal; placebo/control device does not emit PEMF signal
Other Name: Orthofix rotator cuff soft tissue stimulator




Primary Outcome Measures :
  1. retear rate [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Muscle Strength [ Time Frame: 12 months ]
    Strength to be measured using the IsoForceEvo2 dynamometer in subjects treated with PEMF treated and compared with subjects receiving the placebo/control PEMF device

  2. Penn Shoulder Score [ Time Frame: 12 months ]
    100 point scale with three subscales (pain, satisfaction, function) where a 12 pt increase in score with time after PEMF treatment is minimally clinically significant



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject may be male or female between 21 years of age and 80 years of age at the time of consent.
  2. 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.

  3. This must be the first rotator cuff repair surgery on the study shoulder with the following exceptions:

    1. Previous repairs of the teres minor and/or the subscapularis muscles are allowed.
    2. Previous acromioplasties, decompressions, and clavicular fracture repairs are allowed.
    3. Concurrent acromioplasties, subacromial decompressions and/or distal clavicular excisions are permitted.
    4. Concurrent fracture repairs or reconstructions are NOT permitted.
  4. Subject must not have used NSAIDs for one (1) week prior to surgery.
  5. Subjects must agree NOT to use NSAIDS suring the first 6 weeksl of the study and to follow the pain rescue protocol provided by their physician.
  6. Subject must be willing and able to participate in post-operative physical therapy exercises.
  7. Subject must be willing and able to follow all study procedures and return for all study visits.
  8. 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.

    1. When the android version of the mobile app for the RCStim becomes available (est. Dec. 2017), subjects who have reliable access to devices using the android operating systems will be eligible for study inclusion.

8. Subject must be willing to sign an Informed Consent Document.

Exclusion Criteria:

  1. 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.

  2. Subject has a BMI > 45.
  3. Subject has a pacemaker or defibrillator.
  4. Subject is not able to or is unwilling to have an MRI on the study shoulder.
  5. Subject requires assistive devices to walk such as crutches or walkers.
  6. Subject has a rotator cuff tear in which the subscpularis tendon requires repair.

    a. Biceps tenodesis or tenotomy (open or closed) is allowed.

  7. 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

  8. Subject has moderate to severe arthritis based on preoperative imaging or as judged at the time of arthroscopy.

    1. Pre-operative x-ray findings consistent with Grade 3 or Grade4 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

    2. Intra-operative exposed subchondral bone involving >= 50% of either the humeral head, glenoid or both.
  9. Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
  10. 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.
  11. Subject has a metabolic bone disease such as Paget's disease or osteomalacia.
  12. Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
  13. Subject has HIV, hepatitis, or has had an active malignancy in the past 5 years.
  14. Subject has had previous rotator cuff repairs or repairs of the labrum.

    a. See Inclusion Criterion #3 for permitted surgeries.

  15. Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
  16. Subject has shoulder pain of unknown etiology.
  17. Subject has an active or on-going neoplastic disease, except for benign skin cancer(s).
  18. Subject has undergone administration, within the last 30 days, of any type of corticosteroid (with the exception of asthma medications and ophthalmic medications), antineoplastic, immunostimulation or immunosuppressive agent.
  19. Subject is septic or has a local or systemic infection.
  20. Subject has an admitted active substance abuse problem which includes recreational drugs and/or narcotics or a history of substance abuse where history is defined as "not under the care of a physician" for more than 5 years.

    a. Prescriptive medical marijuana is not permitted.

  21. Subject consumes more than 14 (men) or 7 (women) standard drinks (alcoholic units) per week where a drink equals a 12 oz. beer, or a 5 oz. glass of wine, or a 1.5 oz. shot of liquor.
  22. Subject is currently seeking or receiving worker's compensation for this injury or for an injury that has occurred more than12 months prior to enrollment in this study or subjects who are currently in litigation or who have a history of litigation related to musculoskeletal diagnoses.
  23. Subject has a major mental illnesses including major depression, bipolar disorder, schizophrenia or dementia that would prevent them from following the protocol and/or independently completeing the patient reported outcomes measures.
  24. Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies.
  25. Subject has a mental or physical condition that would prevent tem from complying with the study protocol.
  26. Subject has any other condition that, in the opinion of the investigator, would prevent them from completing the study.
  27. Subject is a prisoner.
  28. Subject has participated in another clinical trial within the last 90 days. a. The last study visit attended by the subject starts the 90 day window.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339492


Locations
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United States, Arizona
The CORE Institute
Phoenix, Arizona, United States, 85023
United States, California
Stanford University
Redwood City, California, United States, 94063
UCSF Orthopedics
San Francisco, California, United States, 94158
United States, Florida
Coastal Orthopedics and Sports Medicine
Bradenton, Florida, United States, 34209
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33334
Andrews Institute
Gulf Breeze, Florida, United States, 32561
United States, Georgia
The Hughston Clinic
Columbus, Georgia, United States, 31909
United States, Maryland
Univ. of Maryland Dept of Orthopedics
Baltimore, Maryland, United States, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Michigan
Univ of Michigan Orthopedic Sports Medicine Program
Ann Arbor, Michigan, United States, 48106
United States, New York
Univ Orthopedics Associates at Great Neck
Great Neck, New York, United States, 11021
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati Sports Medicine
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Univ. of Pennsylvania Orthopedics
Philadelphia, Pennsylvania, United States, 19104
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
South Carolina Sports Medicine and Orthopedics
North Charleston, South Carolina, United States, 29406
United States, Texas
Bellaire Orthopedics
Houston, Texas, United States, 77401
Cleveland Clinic Florida
Weston, Texas, United States, 33331
United States, Virginia
Atlantic Orthopedics
Virginia Beach, Virginia, United States, 23456
Sponsors and Collaborators
Orthofix Inc.
Investigators
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Principal Investigator: James T Ryaby, Ph.D. Orthofix Inc.

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Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT03339492     History of Changes
Other Study ID Numbers: CP-1604PSRC
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Orthofix Inc.:
rotator cuff
PEMF
Pulsed Electromagnetic Field
Rotator Cuff Repair
adjunctive therapy

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries