Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.
Evaluate the efficacy and safety/tolerability of cryoneurolysis for reduction of pain and symptoms associated with knee osteoarthritis (OA).



Randomized, double-blind, sham-controlled, multicenter trial with a 6-month follow-up in patients with mild-to-moderate knee OA. Patients were randomized 2:1 to cryoneurolysis targeting the infrapatellar branch of the saphenous nerve (IPBSN) or sham treatment. The primary endpoint was the change from baseline to Day 30 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score adjusted by the baseline score and site. Secondary endpoints, including visual analogue scale (VAS) pain score and total WOMAC score, were tested in a pre-defined order.



The intent-to-treat (ITT) population consisted of 180 patients (n = 121 active treatment, n = 59 sham treatment). Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (P = 0.0004), Day 60 (P = 0.0176), and Day 90 (P = 0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device- or procedure-related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse device effects (ADE).



Cryoneurolysis of the IPBSN resulted in statistically significant decreased knee pain and improved symptoms compared to sham treatment for up to 150 days, and appeared safe and well tolerated.
Injury Care Medical Center, 4850 N. Rosepoint Way, Ste 100, Boise, ID 83713, USA.
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Radnovich
Spokane Joint Replacement Center, 785 E Holland Avenue, Spokane, WA 99218, USA.
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Scott
Kansas City Bone & Joint Clinic, 10701 Nall Avenue, #200, Overland Park, KS 66211, USA.
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Patel
OrthoIllinois, 5875 Riverside Blvd., Rockford, IL 61114, USA.
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Olson
Department of Orthopaedics, LSU School of Medicine, 1542 Tulane Avenue, Box T6-7, New Orleans, LA 70112, USA.
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Dasa
Kansas University Medical Center, Rehabilitation Medicine, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.
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Segal
Center for Musculoskeletal Health, UC Davis Health System, 4625 2nd Avenue, Suite 2006, Sacramento, CA 95817, USA.
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Lane
Shrock Orthopedic Research, 1414 SE 3rd Avenue, Fort Lauderdale, FL 33316, USA.
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Shrock
South Florida Clinical Research, LLC, 7000 SW 62nd Avenue, Suite 590, South Miami, FL 33143, USA.
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Naranjo
Covington Orthopedic and Sport Medicine Institute, 19343 Sunshine Avenue, Covington, LA 70433, USA.
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K
Darr
Health Awareness, Inc., 411 West Indiantown Road, Jupiter, FL 33458, USA.
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Surowitz
Pain Consultants of East Tennessee, 1128 E. Weisgarber Road., Suite 100A, Knoxville, TN 37909, USA.
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Choo
Coastal Orthopedics, 6015 Pointe West Blvd, Bradenton, FL 34209, USA.
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Valadie
Triangle Orthopaedic Associates, 120 William Penn Plaza, Durham, NC 27704, USA.
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Harrell
Arthritis Treatment Center, 71 Thomas Johnson Drive, Frederick, MD 21702, USA.
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Wei
Covina Arthritis Clinic, 500 W. San Bernardino Road, Suite A, Covina, CA 91722, USA.
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Metyas
D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage; D018771:Arthralgia / Q000517:prevention & control*; D003080:Cold Temperature; D017679:Cryotherapy / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009407:Nerve Block / Q000009:adverse effects / Q000379:methods; D009609:Nitrous Oxide / Q000008:administration & dosage; D020370:Osteoarthritis, Knee / Q000628:therapy*; D010147:Pain Measurement; D010329:Patella / Q000294:innervation; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D009609:Nitrous Oxide
Cryoneurolysis; Function; Knee osteoarthritis; Minimally invasive; Pain