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.
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
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)
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