Cryoneurolysis for Improvements in Pain, ADL and QOL in Patients With Ankle Osteoarthritis

NCT03567187 | Completed Results FDA Device

• 1 other identifier: STUDY00142298
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment.

Conditions

Ankle Osteoarthritis

Keywords

Cryoneurolysis; iovera; Superficial nerves treatment; Deep Fibular Nerve

Outcome Measures

Primary Outcomes (1)

• FAOS - PAIN

  FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

  Change between baseline/screening and 12-weeks following treatment

Secondary Outcomes (11)

• NRS Pain Over Prior 7 Days

  change between baseline/screening and 6-weeks following treatment

• FAOS - ADL(Activity of Daily Living)

  change between baseline/screening and 12-weeks following treatment

• FAOS - ADL(Activity of Daily Living)

  change between baseline/screening and 6-weeks following treatment

• FAOS - ADL(Activity of Daily Living)

  change between baseline/screening and 24-weeks following treatment

• FAOS-QoL(Quality of Life)

  change between baseline/screening and 12-weeks following treatment

Other Outcomes (3)

• Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 6-weeks Following Treatment

  change between baseline/screening and 6-weeks following treatment

• Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 12-weeks Following Treatment

  change between baseline/screening and 12-weeks following treatment

• Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 24-weeks Following Treatment

  change between baseline/screening and 24-weeks following treatment

Study Arms (1)

Iovera

EXPERIMENTAL

The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue.

Device: iovera

Interventions

iovera DEVICE

The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

Iovera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in an institutional review board-approved informed consent process, culminating in providing written consent.
• Willingness and ability to comply with the study procedures, visit schedules and ability to follow verbal and written instructions.
• Male or female over 18 years of age.
• Currently Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the ankle based on X-ray (weight-bearing mortise views with 20° internal rotation) or weight-bearing CT scan of the ankles.
• Limited by unilateral ankle pain, rated on a Numerical Rating Scale for pain severity as ≥5 on most days over the last month.
• Foot and ankle outcome score (FAOS) of \< 75 in at least 1 category.
• Body mass index (BMI) ≤ 50 kg/m2
• Ambulatory
• Willingness to abstain from the use of protocol-restricted medications during the study and also willing to abstain from use of analgesics other than acetaminophen 1 week prior to beginning of the study.
• Has undergone at least one prior conservative osteoarthritis treatment (e.g. physical therapy, analgesics).

You may not qualify if:

• Baseline knee, hip, spine or other limitations that affect walking ability to a greater extent than the ankle.
• Cryoglobulinemia, paroxysmal cold hemoglobinuria, Raynaud's disease, cold urticaria.
• Clinical signs or symptoms of active or recurrent infection in the index ankle joint or overlying skin.
• Intra-articular, intravenous or intramuscular corticosteroid (investigational or marketed) within 3 months of screening
• Oral corticosteroids (investigational or marketed) within 2 weeks of screening (unless on a chronic stable dose for ≥3 months prior to enrollment).
• Women who are pregnant (due to potential for the change in body mass and distribution to alter ankle symptoms over the period of follow-up).
• Any condition other than OA of the ankle joint which, in the opinion of the investigators, affects their ability to ambulate to a sufficient degree to interfere with the assessment of the safety and treatment effects of the study injection.
• Arthroscopy or open surgery of the ankle joint within 6 months of screening.
• Planned/anticipated surgery of the index ankle joint during the 6-month study period.
• Any clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection.
• Skin breakdown at the ankle joint where the injection is planned to take place.
• Participated in any investigational drug or device trial within 30 days prior to screening or concurrent participation in another research study that could complicate interpretation of the findings of either study.
• Current consumption of more than 14 alcoholic drinks per week.
• Patients with diffuse pain conditions (Complex pain - diffuse or confounding pain, fibromyalgia, etc.).
• Known altered nerve anatomy or physiology (e.g. neuropathy) at the target, such as due to a congenital, traumatic or surgical cause.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (13)

• Ward ST, Williams PL, Purkayastha S. Intra-articular corticosteroid injections in the foot and ankle: a prospective 1-year follow-up investigation. J Foot Ankle Surg. 2008 Mar-Apr;47(2):138-44. doi: 10.1053/j.jfas.2007.12.007.

  PMID: 18312921 BACKGROUND

• Valderrabano V, Horisberger M, Russell I, Dougall H, Hintermann B. Etiology of ankle osteoarthritis. Clin Orthop Relat Res. 2009 Jul;467(7):1800-6. doi: 10.1007/s11999-008-0543-6. Epub 2008 Oct 2.

  PMID: 18830791 BACKGROUND

• Repetto I, Biti B, Cerruti P, Trentini R, Felli L. Conservative Treatment of Ankle Osteoarthritis: Can Platelet-Rich Plasma Effectively Postpone Surgery? J Foot Ankle Surg. 2017 Mar-Apr;56(2):362-365. doi: 10.1053/j.jfas.2016.11.015.

  PMID: 28231968 BACKGROUND

• Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

  PMID: 16880882 BACKGROUND

• Evans PJ, Lloyd JW, Green CJ. Cryoanalgesia: the response to alterations in freeze cycle and temperature. Br J Anaesth. 1981 Nov;53(11):1121-7. doi: 10.1093/bja/53.11.1121.

  PMID: 7326160 BACKGROUND

• Golightly YM, Devellis RF, Nelson AE, Hannan MT, Lohmander LS, Renner JB, Jordan JM. Psychometric properties of the foot and ankle outcome score in a community-based study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2014 Mar;66(3):395-403. doi: 10.1002/acr.22162.

  PMID: 24023029 BACKGROUND

• Mani SB, Do H, Vulcano E, Hogan MV, Lyman S, Deland JT, Ellis SJ. Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Bone Joint J. 2015 May;97-B(5):662-7. doi: 10.1302/0301-620X.97B5.33940.

  PMID: 25922461 BACKGROUND

• Holzer N, Salvo D, Marijnissen AC, Vincken KL, Ahmad AC, Serra E, Hoffmeyer P, Stern R, Lubbeke A, Assal M. Radiographic evaluation of posttraumatic osteoarthritis of the ankle: the Kellgren-Lawrence scale is reliable and correlates with clinical symptoms. Osteoarthritis Cartilage. 2015 Mar;23(3):363-9. doi: 10.1016/j.joca.2014.11.010. Epub 2014 Nov 15.

  PMID: 25463444 BACKGROUND

• Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004.

  PMID: 11642530 BACKGROUND

• Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476.

  PMID: 23965711 BACKGROUND

• Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.

  PMID: 23680877 BACKGROUND

• McDaniel G, Renner JB, Sloane R, Kraus VB. Association of knee and ankle osteoarthritis with physical performance. Osteoarthritis Cartilage. 2011 Jun;19(6):634-8. doi: 10.1016/j.joca.2011.01.016. Epub 2011 Feb 19.

  PMID: 21310252 BACKGROUND

• Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

  PMID: 28336454 RESULT

Results Point of Contact

• Title: Neil Segal, MD
• Organization: University of Kansas Medical Center

segal-research@kumc.edu

9135740961

Study Officials

• Neil A Segal, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: July 3, 2018
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)