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

NCT03339492 | Terminated DMC FDA Device

• 1 other identifier: CP-1604PSRC
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 23

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.

Conditions

Full-thickness Rotator Cuff Tear

Keywords

rotator cuff; PEMF; Pulsed Electromagnetic Field; Rotator Cuff Repair; adjunctive therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Muscle Strength

  12 months

• Penn Shoulder Score

  12 months

Study Arms (2)

Active PEMF

ACTIVE COMPARATOR

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

Control/placebo PEMF

SHAM COMPARATOR

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

Interventions

RCStim Model 1114 DEVICE

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

Also known as: Orthofix rotator cuff soft tissue stimulator

Active PEMF; Control/placebo PEMF

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (23)

The CORE Institute

Phoenix, Arizona, 85023, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

UCSF Orthopedics

San Francisco, California, 94158, United States

Location

Sabesan Orthopedics Research

Atlantis, Florida, 33462, United States

Location

Coastal Orthopedics and Sports Medicine

Bradenton, Florida, 34209, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33334, United States

Location

Andrews Institute

Gulf Breeze, Florida, 32561, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Univ. of Maryland Dept of Orthopedics

Baltimore, Maryland, 21201, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Univ of Michigan Orthopedic Sports Medicine Program

Ann Arbor, Michigan, 48106, United States

Location

Univ Orthopedics Associates at Great Neck

Great Neck, New York, 11021, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Cincinnati Sports Medicine

Cincinnati, Ohio, 45242, United States

Location

Univ. of Pennsylvania Orthopedics

Philadelphia, Pennsylvania, 19104, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

South Carolina Sports Medicine and Orthopedics

North Charleston, South Carolina, 29406, United States

Location

The Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Deutsch Shoulder

Houston, Texas, 77401, United States

Location

Atlantic Orthopedics

Virginia Beach, Virginia, 23456, United States

Location

Jordan-Young Research Institute

Virginia Beach, Virginia, 23462, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 13, 2017
• Study Start: January 15, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)