INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE

NCT06700109 | Active Not Recruiting FDA Device

• 1 other identifier: BXT-786-KPM-03
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 15

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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

osteoarthritis; knee pain; osteoarthritis of the knee; knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness

  The proportion of subjects whose knee pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment.

  3 months

• Primary Safety

  Aggregate serious device-related adverse events through final follow up visit.

  6 months

Secondary Outcomes (7)

• Secondary Effectiveness

  6 months

• NRS Scores

  6 months

• Pain medication usage

  6 months

• PGIC scores

  6 months

• KOOS, JR scores

  6 months

Other Outcomes (3)

• Patient-Specific Functional Scale (PSFS)

  6 months

• Knee procedures specific Healthcare Utilization Data

  6 months

• EQ-5D-5L Global Quality of Life measure

  6 months

Study Arms (2)

Neural Ice injections

EXPERIMENTAL

This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.

Device: Neural Ice

Corticosteroid injection

ACTIVE COMPARATOR

Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.

Drug: Triamcinolone acetate

Interventions

Neural Ice DEVICE

This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.

Neural Ice injections

Triamcinolone acetate DRUG

A single dose of Triamcinolone 40mg injected directly into the joint space.

Corticosteroid injection

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 to 80, inclusive of any gender
• 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
• Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, or 4) on plain x-rays obtained within the previous 12 months
• At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
• Agree to see one doctor (study investigator) for knee pain during the study period
• Willing/able to understand the informed consent form and provide written informed consent
• Able to complete outcome measures (including electronic patient reported outcome measures)

You may not qualify if:

• Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
• History of cryoglobulinemia
• History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
• History of cold urticaria
• History of Chilblain's (pernio) disease in the lower extremities
• History of Raynaud's disease
• Open and/or infected wounds or active tumor at or near the treatment site
• History of vascular surgery involving femoral vessels on the injection side
• 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
• Active bacterial or fungal infection that at the discretion of the investigator would preclude study participation
• Currently taking \>60 MME/day, as determined per MDcalc.com (opioid conversion calculator)
• History of History of systemic inflammatory conditions such as rheumatoid arthritis
• Bleeding disorders anticoagulant therapy, unless appropriately stopped or reversed for the procedure
• 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
• Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months

Sponsors & Collaborators

• Brixton Biosciences, Inc.: lead

Study Sites (15)

Marin Health

Larkspur, California, 94939, United States

Location

Centers for Advanced Orthopedics

Washington D.C., District of Columbia, 20036, United States

Location

The Orthopaedic Institute

Gainesville, Florida, 32607, United States

Location

Emory University

Johns Creek, Georgia, 30097, United States

Location

Insight Hospital and Medical Center Chicago

Chicago, Illinois, 60616, United States

Location

NextStage Clinical Research Advanced Orthopaedic Associates

Wichita, Kansas, 67226, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70115, United States

Location

NextStage Clinical Research Regenerative Orthopedics and Sports Medicine

North Bethesda, Maryland, 20852, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Insight Research Institute

Flint, Michigan, 48507, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73034, United States

Location

NextStage Clinical Research The Orthopedic Center

Tulsa, Oklahoma, 74104, United States

Location

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, 15143, United States

Location

NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute

Houston, Texas, 77058, United States

Location

UT San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (15)