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

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

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 Overview

• Status: Terminated
• Conditions: Full-thickness Rotator Cuff Tear
• Intervention / Treatment: Device: RCStim Model 1114

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.

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 permitted.
   2. Previous acromioplasties, decompressions, and clavicular fracture repairs are permitted.
   3. Concurrent acromioplasties, subacromial decompressions and/or distal clavicular excisions are permitted.
   4. Concurrent fracture repairs or reconstructions are NOT permitted.
   5. Biceps tenodesis or tenotomy (open or closed) are 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 weeks of the study. Low dose aspirin (81 mg) is permitted.
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.
9. Subject must understand and be willing to sign the IRB-approved 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 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

   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.

    a. Subjects with osteoporosis are not excluded from the study.

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, including CBD oils.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Orthofix rotator cuff soft tissue stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retear rate	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	Strength to be measured using the IsoForceEvo2 dynamometer in subjects treated with PEMF treated and compared with subjects receiving the placebo/control PEMF device	12 months
Penn Shoulder Score	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	12 months

Collaborators and Investigators

• Sponsor: Orthofix Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: adjunctive therapy; rotator cuff; PEMF; Rotator Cuff Repair; Pulsed Electromagnetic Field
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: CP-1604PSRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes