None listed
Conditions
Brief summary
The primary objective of the proposed study is to evaluate the safety and tolerability of the Coolio System when administered as a genicular nerve block for pain management in subjects with osteoarthritis of the knee. The secondary objective of the study is to observe analgesic performance of the device. The Coolio System intends to utilize cold temperatures to temporarily inhibit nerve signaling through the injection of Neural Ice into the extra-neural space of target sensory nerves. Brixton Biosciences hypothesizes that the injection of Neural Ice around three genicular nerves in the knee can reduce knee pain associated with osteoarthritis. The anesthesiologist-investigator will inject Neural Ice around these three nerves and evaluate pain scores and other assessments throughout a 6-month follow-up period.
Interventions
The Coolio System is a medical device that consists of syringes pre-filled with Neural Ice (non-pharmaceutical). Neural Ice is an injectate that relies on a physical mechanism of action, where cold temperatures are used to impact a nerve.
This study will require an anesthesiologist-investigator to inject Neural Ice into three target locations around the knee in patients experiencing pain from osteoarthritis. The three target locations that Neural Ice will be injected into are the superolateral,
The Coolio System is a medical device that consists of syringes pre-filled with Neural Ice (non-pharmaceutical). Neural Ice is an injectate that relies on a physical mechanism of action, where cold temperatures are used to impact a nerve. This study will require an anesthesiologist-investigator to inject Neural Ice into three target locations around the knee in patients experiencing pain from osteoarthritis. The three target locations that Neural Ice will be injected into are the superolateral, superomedial, and inferomedial genicular nerves. Each injection site will receive 20mL of Neural Ice. The intervention is expected to take less than 15 minutes. The eCRF will include a genicular block procedure page where coordinators will document whether each step of the intervention was adhered to. The study will evaluate whether the Coolio System reduces pain associated with osteoarthritis of the knee through the assessment of pain scores and functional tests. Materials that will be used during the intervention include syringes pre-filled with Neural Ice, injection needles, extension tubing, and Luer connectors. This intervention will only be administered to each subject once throughout the study in a procedure room located in the pain management clinic. Subjects will be followed for a total of 6 months, with weekly follow-up visits with the investigator.
Sponsors
Brixton Biosciences
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Baseline pain intensity of at least 5 on the Numeric Rating Scale (NRS), despite current treatment - A decrease of at least 50% from baseline Numeric Rating Scale (NRS) with diagnostic genicular nerve block - Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, 4) on plain x-rays - Failed conservative treatments (NSAIDs, acetaminophen, physical therapy, and cortisone injections).
Exclusion criteria
- 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 - Currently taking >60 MME/day, as determined per opioid conversion calculator - Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months - Use of intra-articular injection of corticosteroid, hyaluronic acid, prolotherapy, autologous blood, or platelet rich plasma injections for the index knee within the previous 3 months
Outcome results
None listed