An Open-label Trial of Cryoneurolysis for Improvements in Pain, Activities of Daily Living and Quality of Life in Patients With Ankle Osteoarthritis

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.

Eligibility Criteria

Inclusion Criteria:

- Written consent to participate in the study following participation in an
institutional review board-approved informed consent process.

- 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)

- Limited by unilateral ankle pain, rated on a Numerical Rating Scale for pain severity
as ≥5 on ≥15 days over the last month.

- Foot and ankle outcome score (FAOS) of < 75 in 3 or more categories.

- Body mass index (BMI) ≤ 40 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).

Exclusion Criteria:

- Baseline knee, hip, spine or other limitations that affect walking ability.

- Cryoglobulinemia, paroxysmal cold hemoglobinuria, Raynaud's disease, cold urticaria.

- History of infection in the index ankle joint or overlying skin, or clinical signs or
symptoms of active ankle infection

- IA, IV or IM corticosteroid (investigational or marketed) within 3 months of screening

- Oral corticosteroids (investigational or marketed) within 2 weeks of screening.

- 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

- Use of opioid medications on most or all days over the past 3 months.

- Clinical judgment concerning participant safety or noncompliance

- Patients with diffuse pain conditions (Complex pain - diffuse or confounding pain,
fibromyalgia, etc.)

- Known altered nerve anatomy at the target, such as due to a congenital, traumatic or
surgical cause.

Principal Investigator

Neil A Segal, MD

Study Contact

Shenequa Deas, MPH, sdeas@kumc.edu, 913-574-0949

Estimated Completion Date

Friday, March 1, 2019

ClinicalTrials.gov #

NCT03567187
06/24/2018