Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03877653

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.

Not Eligible

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

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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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