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Lay Description

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

  • Other
IRB Number
STUDY00001111
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

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

Study Design

A Multi-Center, Randomized, Controlled Study

Study Contact


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

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

Principal Investigator
Mark Foster