Clinical trial NCT06700109: INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE
Official title: INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE: A MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY (ICE STUDY)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Keywords: osteoarthritis
knee pain
osteoarthritis of the knee
knee osteoarthritis
Lead sponsor: Brixton Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 263
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of Neural Ice for pain management associated with knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.


Eligibility criteria: 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 Confidential Brixton Biosciences Inc. Page 12 of 53 Version: 1.1, 30 August 2024
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, Confidential Brixton Biosciences Inc. Page 13 of 53 Version: 1.1, 30 August 2024 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

Primary outcomes:
measure: Primary Effectiveness
timeFrame: 3 months
measure: Primary Safety
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Effectiveness
timeFrame: 6 months
measure: NRS Scores
timeFrame: 6 months
measure: Pain medication usage
timeFrame: 6 months
measure: PGIC scores
timeFrame: 6 months
measure: KOOS, JR scores
timeFrame: 6 months
measure: Onset of pain relief defined as pain reduced by 30% based on NRS score from baseline
timeFrame: 6 months
measure: Change in Timed-Up and Go (TUG) test scores from baseline
timeFrame: 6 months
Other outcomes:
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: 6 months
measure: Knee procedures specific Healthcare Utilization Data
timeFrame: 6 months
measure: EQ-5D-5L Global Quality of Life measure
timeFrame: 6 months
Locations:
city: Larkspur
country: United States
facility: Marin Health
state: California
city: Washington
country: United States
facility: Centers for Advanced Orthopedics
state: District of Columbia
city: Gainesville
country: United States
facility: The Orthopaedic Institute
state: Florida
city: Johns Creek
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Insight Hospital and Medical Center Chicago
state: Illinois
city: Wichita
country: United States
facility: NextStage Clinical Research Advanced Orthopaedic Associates
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: North Bethesda
country: United States
facility: NextStage Clinical Research Regenerative Orthopedics and Sports Medicine
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Flint
country: United States
facility: Insight Research Institute
state: Michigan
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: NextStage Clinical Research The Orthopedic Center
state: Oklahoma
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Houston
country: United States
facility: NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute
state: Texas
city: San Antonio
country: United States
facility: UT San Antonio
state: Texas
Study officials:
References: