Status:
TERMINATED
Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
Lead Sponsor:
Amp Orthopedics, Inc.
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
40-80 years
Phase:
NA
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01507818
Start Date
December 1 2011
End Date
October 1 2012
Last Update
July 9 2012
Active Locations (3)
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1
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
2
Mississippi sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States, 39202
3
Taos Orthopaedic Institue
Taos, New Mexico, United States, 87571