Actively Recruiting
Freedom-1 Study for Chronic Knee Pain
Led by Curonix LLC · Updated on 2025-02-13
100
Participants Needed
13
Research Sites
299 weeks
Total Duration
On this page
Sponsors
C
Curonix LLC
Lead Sponsor
T
Texas Institute for Pain and spine
Collaborating Sponsor
AI-Summary
What this Trial Is About
To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.
CONDITIONS
Official Title
Freedom-1 Study for Chronic Knee Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
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.
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Western Clinical Research
Placentia, California, United States, 92870
Actively Recruiting
2
Colorado Pain Care, LLC
Denver, Colorado, United States, 80222
Actively Recruiting
3
Holy Cross Hospital, Inc
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
4
Florida Joint Care Institute
Trinity, Florida, United States, 34655
Actively Recruiting
5
Southern Pain and research
Jasper, Georgia, United States, 30143
Actively Recruiting
6
Vista Clinical Research/Summit Spine & Joint Centers
Newnan, Georgia, United States, 30265
Actively Recruiting
7
Desert Orthopaedic Center
Las Vegas, Nevada, United States, 89149
Actively Recruiting
8
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, United States, 45459
Actively Recruiting
9
Premier Pain Treatment
Loveland, Ohio, United States, 45140
Actively Recruiting
10
Kettering Health
Miamisburg, Ohio, United States, 45429
Actively Recruiting
11
Austin Orthopedic Institute
Austin, Texas, United States, 78759
Actively Recruiting
12
Performance pain and sports medicine
Houston, Texas, United States, 77027
Actively Recruiting
13
Advanced Spine and Pain Center
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
N
Niek Vanquathem, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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