Rotator Cuff Tear
Conditions
Keywords
Arthroscopic Rotator Cuff Repair, Electromagnetic field treatment, Pulsed Radio Frequency treatment, Non-invasive, Non-thermal
Brief summary
To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (Sham).
Interventions
DEVICEIvivi Torino II
Emits a PRF generated specific electromagnetic signal consisting of a 27.12 MHz radio frequency carrier pulse-modulated with a burst duration of 3 milliseconds repeating at 2 times per second (2Hza0\>
DEVICEInactive Sham device
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
Sponsors
Amp Orthopedics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* MRI diagnosis of rotator cuff tear * Persistent symptoms despite a minimum of 6 months of failed non-operative management * Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule). * Age 40 to 80 years * Able to read and complete English-language surveys * Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects * Willingness and ability to comply with study product and methods
Exclusion criteria
* Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis * Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator) * Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer * Chronic narcotic pain medication dependency * Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion * Worker's compensation claimant * Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment * Use of oral prednisone in the past 30 days * Use of any investigational drug or participation in another research study within the past 30 days * Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily narcotic consumption (oxycodone mg) | week-1 post surgery | Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average daily narcotic consumption (oxycodone mg) | Weeks 2-6 post surgery | Average, daily, patient-reported narcotic consumption during Weeks 2-6 |
| Visual Analogue Scale (VAS) pain | Weeks 2-6 post surgery | Daily VAS pain (daily current and maximum) during Week 1, VAS pain (daily current and maximum) during Weeks 2-6 |
| Patient-reported general health-related quality of life score (EQ-5D) | On the last day of Weeks 1-6 | The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6) |
| Adverse Events | Weeks 1-6 post surgery | Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety |
Countries
United States
Outcome results
None listed