Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06700109 | RECRUITING | Osteoarthritis (OA) of the Knee

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

Brixton Biosciences, Inc.

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.

Condition or disease

Osteoarthritis (OA) of the Knee

Intervention/treatment

Neural Ice

Triamcinolone acetate

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 263 participants
Masking : SINGLE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-11-19
Estimated Primary Completion Date : 2027-02-01
Estimated Study Completion Date : 2027-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE

Location Details

NCT06700109

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

Marin Health

Lark spruce, California, United States, 94939

NOT YET RECRUITING

United States, District of Columbia

Centers for Advanced Orthopedics

Washington, District of Columbia, United States, 20036

RECRUITING

United States, Florida

The Orthopaedic Institute

Gainesville, Florida, United States, 32607

RECRUITING

United States, Georgia

Emory University

Johns Creek, Georgia, United States, 30097

NOT YET RECRUITING

United States, Illinois

Insight Hospital and Medical Center Chicago

Chicago, Illinois, United States, 60616

RECRUITING

United States, Kansas

NextStage Clinical Research Advanced Orthopaedic Associates

Wichita, Kansas, United States, 67226

NOT YET RECRUITING

United States, Louisiana

Ochsner Health System

New Orleans, Louisiana, United States, 70115

SUSPENDED

United States, Maryland

NextStage Clinical Research Regenerative Orthopedics and Sports Medicine

North Bethesda, Maryland, United States, 20852

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Road cancer

Insight Research Institute

Flint, Road cancer, United States, 48507

RECRUITING

United States, Oklahola

Clinical Investigations, LLC

Edmond, Okholohan, United States, 73034

RECRUITING

United States, Oklahola

NextStage Clinical Research The Orthopedic Center

Tulsa, Okholohan, United States, 74104

RECRUITING

United States, Pennsylvania

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, United States, 15143

RECRUITING

United States, Texas

NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute

Houston, Texas, United States, 77058

NOT YET RECRUITING

United States, Texas

UT San Antonio

San Antonio, Texas, United States, 78229