Purpose

Evaluate the safety and analgesic performance of the Neural Ice™ device in subjects with moderate to severe pain due to osteoarthritis of the knee compared to subjects receiving treatment with intraarticular corticosteroid injection.

Category

IRB Number
STUDY00001111
NCT Number
-
Open to Enrollment
Yes
Sponsor
-



Study Contact

Overall Recruitment Point of Contact
Omer Bakal
210-567-4503
bakalo@uthscsa.edu

Principal Investigator
Mark Foster

Regulatory Point of Contact
Stephanie Perez
210-450-8973
perezs11@uthscsa.edu



Eligibility

Eligible Ages
-
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. Age 22 to 80, inclusive of any gender

    2. Baseline pain intensity of >5 of the Numeric Rating Scale

    (NRS) despite current treatment

    3. Chronic symptomatic osteoarthritis of the knee (K-L stage

    2, 3, or 4) on plain x-rays obtained within the previous 12

    months

    4. At least 3 months of previous conservative treatments

    (NSAID, acetaminophen, physical therapy, cortisone

    injections) that are not currently providing relief

    5. Agree to see one doctor (study investigator) for knee pain

    during the study period

    6. Willing/able to understand the informed consent form and

    provide written informed consent

    7. Able to complete outcome measures (including electronic

    patient reported outcome measures)

Exclusion Criteria

    1. Known allergy to glycerol, hyaluronic acid, poloxamer 407,

    or phosphate buffered saline

    2. History of cryoglobulinemia

    3. History of cold-induced auto-immune hemolytic anemia

    (e.g. paroxysmal cold hemoglobinuria or cold agglutinin

    disease)

    4. History of cold urticaria

    5. History of Chilblain’s (pernio) disease in the lower

    extremities

    6. History of Raynaud’s disease

    7. Open and/or infected wounds or active tumor at or near the

    treatment site

    8. History of vascular surgery involving femoral vessels on the

    injection side

    9. History of surgical procedures to affected limb that, in the

    opinion of the investigator, could have impacted the

    integrity of the genicular nerves or blood vessels

    10. Active bacterial or fungal infection that at the discretion of

    the investigator would preclude study participation

    11. Currently taking >60 MME/day, as determined per

    MDcalc.com (opioid conversion calculator)

    12. History of History of systemic inflammatory conditions such

    as rheumatoid arthritis

    13. Bleeding disorders anticoagulant therapy, unless

    appropriately stopped or reversed for the procedure

    14. Any condition or circumstance that would impact or

    confound assessment of safety and/or pain. For example,

    comorbid or concomitant pain conditions, pre-existing lower

    limb neurologic deficits, any psychiatric or neurologic

    disease

    15. Cryoneurolysis, thermal or pulsed radiofrequency ablation,

    or phenol injection for the index knee within the past 12

    months

    16. Use of intra-articular injection of corticosteroid within the

    previous 3 months, or hyaluronic acid, prolotherapy,

    autologous blood, or platelet rich plasma injections for the

    index knee within the previous 6 months

    17. Known contraindication to use of a regional anesthetic

    block

    18. Pregnant, nursing or intent of becoming pregnant during

    the study period

    19. Any condition (such as history of significant cardiovascular,

    renal failure/dialysis, hepatic or other systemic

    comorbidity/chronic pain condition) or circumstance that, in

    the opinion of the investigator, would compromise the

    safety of the subject or the quality of study data

    20. Body habitus/knee anatomy that would preclude the use of

    the product injection needle size

    21. Participation in any clinical study of a therapeutic

    investigational product within 30 days prior to enrollment

    22. Unwilling to refrain from participation in any other clinical

    study through the duration of this study

    23. Unwilling to refrain from any scheduled surgeries during the

    duration of this study