Full-thickness Rotator Cuff TearRCStimNCT03339492
PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears
A study testing RCStim Model 1114 in people with Full-thickness Rotator Cuff Tear, run by Orthofix Inc. at 23 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Full-thickness Rotator Cuff Tear
- What is being tested?
- RCStim Model 1114
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 23 sitesUnited States
- Study dates
- 15 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- Subject has a tear <1cm or >5cm in size measured intraoperatively, pre-debridement, using a calibrated probe.
- 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.
Show all 38Show fewer
- Subject has a rotator cuff tear in which the subscpularis tendon requires repair.
- 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.
- 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.
- 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.
- Subject has an active or on-going neoplastic disease, except for benign skin cancer(s).
- 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.
- Subject is septic or has a local or systemic infection.
- 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.
- Prescriptive medical marijuana is not permitted, including CBD oils.
- 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.
- 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.
- 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.
- Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies.
- Subject has a mental or physical condition that would prevent tem from complying with the study protocol.
- Subject has any other condition that, in the opinion of the investigator, would prevent them from completing the study.
- Subject is a prisoner.
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Univ of Michigan Orthopedic Sports Medicine Program
Ann Arbor, Michigan, 48106
Sabesan Orthopedics Research
Atlantis, Florida, 33462
Univ. of Maryland Dept of Orthopedics
Baltimore, Maryland, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Coastal Orthopedics and Sports Medicine
Bradenton, Florida, 34209
Rush University Medical Center
Chicago, Illinois, 60612
Cincinnati Sports Medicine
Cincinnati, Ohio, 45242
Holy Cross Hospital
Fort Lauderdale, Florida, 33334
The Campbell Clinic
Germantown, Tennessee, 38138
Univ Orthopedics Associates at Great Neck
Great Neck, New York, 11021
Andrews Institute
Gulf Breeze, Florida, 32561
Deutsch Shoulder
Houston, Texas, 77401
South Carolina Sports Medicine and Orthopedics
North Charleston, South Carolina, 29406
Univ. of Pennsylvania Orthopedics
Philadelphia, Pennsylvania, 19104
The Rothman Institute
Philadelphia, Pennsylvania, 19107
The CORE Institute
Phoenix, Arizona, 85023
Stanford University
Redwood City, California, 94063
UCSF Orthopedics
San Francisco, California, 94158
University Orthopedics Center
State College, Pennsylvania, 16801
Atlantic Orthopedics
Virginia Beach, Virginia, 23456
Jordan-Young Research Institute
Virginia Beach, Virginia, 23462
Cleveland Clinic Florida
Weston, Florida, 33331
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Full-thickness Rotator Cuff Tear
- Being tested
- RCStim Model 1114
- Keywords
- rotator cuff, PEMF, Pulsed Electromagnetic Field, Rotator Cuff Repair, adjunctive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCStim Model 1114Device
Also called Orthofix rotator cuff soft tissue stimulator
Active device emits PEMF signal; placebo/control device does not emit PEMF signal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: RCStim Model 1114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start15 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Interim results suggested that the study was not adequately powered to achieve the primary endpoint: superiority in retear rate reduction in PEMF treatment versus placebo.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full-thickness Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339492
- Sponsor's protocol ID
- CP-1604PSRC
- Acronym
- RCStim
- Status last verified
- Aug 2023
- First submitted
- 31 Oct 2017
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03339492
- Acronym / sponsor ID
- RCStim / CP-1604PSRC
- Conditions
- Full-thickness Rotator Cuff Tear
- Keywords
- rotator cuff, PEMF, Pulsed Electromagnetic Field, Rotator Cuff Repair, adjunctive therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim results suggested that the study was not adequately powered to achieve the primary endpoint: superiority in retear rate reduction in PEMF treatment versus placebo.
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PEMF | Active comparator | Device: RCStim Model 1114Subjects 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. |
| Control/placebo PEMF | Sham comparator | Device: RCStim Model 1114Subjects 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- This must be the first rotator cuff repair surgery on the study shoulder with the following exceptions:
- 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.
Key exclusion criteria (38 listed)
- Subject has a tear <1cm or >5cm in size measured intraoperatively, pre-debridement, using a calibrated probe.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RCStim Model 1114Also: Orthofix rotator cuff soft tissue stimulatorActive device emits PEMF signal; placebo/control device does not emit PEMF signal | Device | Active PEMF, Control/placebo PEMF |
Primary outcome
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.
2 secondary outcomes
Muscle Strength
Time frame: 12 months
Penn Shoulder Score
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Interim results suggested that the study was not adequately powered to achieve the primary endpoint: superiority in retear rate reduction in PEMF treatment versus placebo.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
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Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
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Cold and Compression After Rotator Cuff Repair (RCR)
High-grade Partial or Full Thickness Rotator Cuff Tears
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RCStim Model 1114 in people with Full-thickness Rotator Cuff Tear, run by Orthofix Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim results suggested that the study was not adequately powered to achieve the primary endpoint: superiority in retear rate reduction in PEMF treatment versus placebo.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retear rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.