Phase
Condition
N/ATreatment
Wireless neuromodulation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
i. Subject is over 18 years of age; ii. Subjects with a history of chronic, function-limiting (m-MPS >6/10) knee pain from osteoarthritis of at least three months in duration with or without prior surgeries; iii. Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year; iv. Subject has been examined and has been deemed to be an appropriate candidate for the procedure, including chronic knee pain in patients post total knee replacement (TKR); v. Subjects who are able to understand this investigation, and give voluntary, written informed consent to participate in this study; vi. Subjects who are able to co-operate with the study procedures and are willing to return to the center for all the required post-operative follow-ups; vii. Documented failure of at least two less invasive treatment modalities including physical therapy, intra-articular steroids and/or oral NSAIDS; viii. Subject has not had recent invasive surgical procedures of the knee within the following intervals in relation to the time of signing Informed Consent:- 2 weeks for steroid injection - 4 weeks for radiofrequency, cryoablation or hyaluronic acid (HA) injection ix. Subject noted good (> 75%) but only temporary relief for at least 2 hours from an infrapatellar saphenous nerve injection with local anesthetic; x. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of assessment of a Clinical Psychologist.
Exclusion
Exclusion Criteria:
xi. Significant contralateral knee pain that would influence their level of activity greater to 6 on the modified-Mankosky Pain Scale; xii. Hip or foot pain greater than knee pain; xiii. Neurogenic or vascular claudication; xiv. Subject has been diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis, confirmed by X-ray studies conducted in the last year; xv. Uncontrolled major depression or uncontrolled psychiatric disorders; xvi. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, infection, unstable angina, and severe chronic obstructive pulmonary disease; xvii. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function (eg. Rheumatoid arthritis, severe spinal stenosis, activity-limiting cardiac disease); xviii. Women who are pregnant or planning to become pregnant, lactating; xix. Body mass index (BMI) greater than 40 (morbid obesity); xx. Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints; xxi. Subject has been examined and has been deemed to be inappropriate for the procedure based on anatomical restrictions; xxii. Lymphedema or stasis ulcers or other conditions that would compromise the surgical site; xxiii. History of adverse reaction to local anesthetic drugs; xxiv. Worker's compensation claimants; xxv. Incarcerated or has an ankle position locator; xxvi. Documented allergy to device material components; xxvii. Known or suspected substance abuse within the last 2 years; xxviii. Pacemaker or implanted defibrillator; xxix. Participation in another clinical study that could confound the results of this study; xxx. Based on the opinion of the investigator any legal or medical concerns that would preclude his/her enrollment in the study or potentially confound the results; xxxi. Any other implanted active medical devices in the same site.
Study Design
Study Description
Connect with a study center
Western Clinical Research
Placentia, California 92870
United StatesActive - Recruiting
Allied Pain and Spine
San Jose, California 95124
United StatesSite Not Available
Colorado Pain Care, LLC
Denver, Colorado 80222
United StatesActive - Recruiting
Holy Cross Hospital, Inc
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Florida Joint Care Institute
Trinity, Florida 34655
United StatesActive - Recruiting
Southern Pain and research
Jasper, Georgia 30143
United StatesActive - Recruiting
Vista Clinical Research/Summit Spine & Joint Centers
Newnan, Georgia 30265
United StatesActive - Recruiting
Global Scientific Innovations LLC
Evansville, Indiana 47714
United StatesSite Not Available
Steward St. Elizabeths Medical Center of Boston
Boston, Michigan 02135
United StatesSite Not Available
Comprehensive and Interventional Pain Management LLP
Henderson, Nevada 89052
United StatesSite Not Available
Desert Orthopaedic Center
Las Vegas, Nevada 89149
United StatesActive - Recruiting
Orthopedic Associates of Southwest Ohio
Dayton, Ohio 45459
United StatesActive - Recruiting
Kettering Adventist Healthcare dba Kettering Health
Kettering, Ohio 45429
United StatesSite Not Available
Premier Pain Treatment
Loveland, Ohio 45140
United StatesActive - Recruiting
Kettering Health
Miamisburg, Ohio 45429
United StatesActive - Recruiting
Main Line Spine
King Of Prussia, Pennsylvania 19406
United StatesSite Not Available
Austin Orthopedic Institute
Austin, Texas 78759
United StatesActive - Recruiting
Performance pain and sports medicine
Houston, Texas 77027
United StatesActive - Recruiting
Texas Institute of Pain and Spine
Pearland, Texas 77584
United StatesSite Not Available
Advanced Spine and Pain Center
San Antonio, Texas 78240
United StatesActive - Recruiting
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