None listed
Conditions
Brief summary
The BXT-786 System used as part of a standard genicular block (block of the knee region) could provide a more effective (potentially reduced pharmaceutical analgesic intake) benefit for patients with unrelieved pain from knee osteoarthritis that are undergoing, or who meet the criteria for, total knee arthroplasty (TKA). (Note: it is not required for the subject to actually have a scheduled TKA, just that they meet the criteria for the procedure). The administration of the BXT-786 Focused Cold Therapy creates a physical effect in the specifically targeted peripheral nerves. without permanently damaging the nerve or injuring surrounding tissues. Based on previous research, it is anticipated that the analgesic effect may last weeks to months. This will allow for the benefit of temporary analgesia without damaging the nerve through a minimally invasive treatment. Over a 12 week period, subjects will participate in live and Telehealth visits, as well as complete a subject diary to aid in the assessment of the research block's safety.
Interventions
Eligible subjects will receive a genicular block (a standard of care procedure that impactis the knee region) utilizing the BXT-786 coolant and delivery system. The research block will be performed by a qualified anesthesiologist. The intervention is a single procedure consisting of three injections. Each injection dose is 20mL of Coolant. The Investigational product consists of a three component system: The BXT-786 coolant (located within the syringe); the BXT-786 syringe; and the BTX-786 d
Eligible subjects will receive a genicular block (a standard of care procedure that impactis the knee region) utilizing the BXT-786 coolant and delivery system. The research block will be performed by a qualified anesthesiologist. The intervention is a single procedure consisting of three injections. Each injection dose is 20mL of Coolant. The Investigational product consists of a three component system: The BXT-786 coolant (located within the syringe); the BXT-786 syringe; and the BTX-786 dock (which processes the coolant within the syringe in preparation of each injection). The investigators have all agreed to a standard procedure for the genicular block and will confirm this with documentation within the research record. The singular research genicular block will typically occur within the clinic/ procedure room. Subjects 1-8 (of 16 total) will have a tourniquet (like blood pressure cuff) and ice pack applied prior to procedure. Procedure: The procedure itself will take approximately twenty minutes, however, with the pre-cooling of injection sites, and post procedure examination, the visit will last approximately 2 hours. The proposed sequence of injections is superomedial, superolateral, and inferomedial. Investigators will agree to observe the following principles: 1. Prior to procedure, all subjects should have completed an informed consent form and all screening procedures. However, should the anesthesiologist’s pre-procedure review note a significant change from screening assessment of the subject, they may deem that the procedure is not in the best interest of the subject and may withdraw them from participation. The subject will not complete enrollment and will be considered a screen failure. 2. Place BXT-786 Syringes into a regular freezer at -22 to -18°C for (minimum) 12 hours prior to injection 3. Instruct patient to change into hospital gown (may remain in clothing if target area is easily accessible) 4. Move patient to procedure room and position on exam table 5. Place patient in supine position with index knee flexed 10-45° 6. Apply a pneumatic, single cuff tourniquet to the mid-thigh – do not inflate. Note: this step is EXCLUDED for subjects 9-16. 7. Prep skin of target area with room temperature 10%(povidone-iodine) betadine 8. Place sterile towel over knee and position ice pack(s) over injection sites, by folding each pack in half and securing with medical tape, for approximately 20 minutes. Use ice pack provided by the Sponsor only. Note: this step is EXCLUDED for subjects 9-16. 9. Remove ice pack(s) and reapply 10% (povidone-iodine) butadiene to the skin of the target area. 10. Anesthetize the skin and soft tissues (within region of each injection site) with 1-2mL of 1% lidocaine 11.Identify the anatomical landmarks of the superomedial, superolateral, and inferomedial genicular nerves of the index knee under ultrasound or fluoroscopic imaging. The following instructions can be utilized for fluoroscopic imaging: • Superomedial Genicular Nerve 1. AP Fluoroscopic View: Needle positioned 1-2cm medial to femoral shaft – confluence of medial femoral shaft and medial epicondyle. Needle advanced until it touches the bone. 2. Lateral Fluoroscopic View: Needle repositioned so tip is positioned half-way across the diameter of the femoral shaft, withdrawn 4mm superficial to periosteum. • Superolateral Genicular Nerve 1. AP Fluoroscopic View: Needle positioned 1-2cm lateral to femoral shaft – confluence of lateral femoral shaft and lateral epicondyle. Needle advanced until it touches the bone. 2. Lateral Fluoroscopic View: Needle repositioned so tip is positioned half-way across the diameter of the femoral shaft, withdrawn 4mm superficial to periosteum. • Inferomedial Genicular Nerve 1. AP Fluoroscopic View: Needle is positioned 2-3cm medial and 3-4cm inferior to tibial shaft – confluence of medial tibial shaft and tibial flare. Needle advanced until it touches the bone. 2. Lateral Fluoroscopic View: Needle repositioned so tip is positioned at the mid-point of the diameter of tibial shaft and withdrawn 4mm superficial to periosteum. 12. Physician to position three 17-gauge, 50-mm, regular bevel needles at the appropriate locations. Note: Use injection needles provided by the Sponsor. 13. Remove stylets from needles and check for blood (if applicable) 14. Inflate tourniquet 50-100mmHg above patient’s systolic blood pressure. Note: this step is EXCLUDED for subjects 9-16. 15. Assistant of physician to retrieve one BXT-786 Syringe from freezer and place into BXT-786 Dock. Note: it is important to immediately transfer Syringe from freezer to Dock – do not leave the Syringe sitting out. 16. BXT-786 Dock will prepare Syringe for approximately 1-2 minutes; wait for blinking green light to indicate that Syringe is ready for injection. Note: it is important to immediately inject Focused Cold Therapy once Syringe has completed preparation. 17. Assistant of physician to remove Syringe from Dock 18. Physician to connect Syringe to needle positioned for superomedial genicular nerve of the index knee 19. Physician to administer 20mL of BXT Focused Cold Therapy into extra-neural space of the superomedial genicular nerve. Do not rub or massage knee once injection has been administered in order to keep Coolant within target area. Discard Syringe and needle. Note: it is important to immediately inject Coolant into patient without delay after removal from the Dock. 20. Repeat steps 14-18 for superolateral genicular nerve 21. Repeat steps 14-18 for inferomedial genicular nerve 22. Deflate and remove tourniquet. Note: this step is EXCLUDED for subjects 11-15. 23. Assistant of physician to remove physician’s outer pair of gloves 24. Place adhesive bandages over injection sites 25. Move patient to recovery area for 5-15 minutes – Assistant/physician to aid patient with mobilization; may require wheelchair 26. During recovery period, physician to perform anesthesia exam, which includes motor, sensory, and vascular evaluations. Allow patient to ask questions, print post-op instructions and follow-up schedule for patient to take home 27. Discharge patient if medically stable and able to ambulate--if patient requires assistance with mobility, provide as per standard of care at institution.
Eligible subjects will receive a genicular block (a standard of care procedure that impactis the knee region) utilizing the BXT-786 coolant and delivery system. The research block will be performed by a qualified physician. The intervention is a single procedure consisting of three injections. Each injection dose is 20mL of Coolant. The Investigational product consists of a three component system: The BXT-786 coolant (located within the syringe); the BXT-786 syringe; and the BTX-786 dock (which
Eligible subjects will receive a genicular block (a standard of care procedure that impactis the knee region) utilizing the BXT-786 coolant and delivery system. The research block will be performed by a qualified physician. The intervention is a single procedure consisting of three injections. Each injection dose is 20mL of Coolant. The Investigational product consists of a three component system: The BXT-786 coolant (located within the syringe); the BXT-786 syringe; and the BTX-786 dock (which processes the coolant within the syringe in preparation of each injection). The investigators have all agreed to a standard procedure for the genicular block and will confirm this with documentation within the research record. The singular research genicular block will typically occur within the clinic/ procedure room. Subjects 1-8 (of 16 total) will have a tourniquet (like blood pressure cuff) and ice pack applied prior to procedure. The procedure itself will take approximately twenty minutes, however, with the pre-cooling of injection sites, and post procedure examination, the visit will last approximately 2 hours. The proposed sequence of injections is superomedial, superolateral, and inferomedial. Investigators will agree to observe the following principles: 1. Prior to procedure, all subjects should have completed an informed consent form and all screening procedures. However, should the Investigator's pre-procedure review note a significant change from screening assessment of the subject, they may deem that the procedure is not in the best interest of the subject and may withdraw them from participation. The subject will not complete enrollment and will be considered a screen failure. 2. Place BXT-786 Syringes into a regular freezer at -22 to -18°C for (minimum) 12 hours prior to injection 3. Instruct patient to change into hospital gown (may remain in clothing if target area is easily accessible) 4. Move patient to procedure room and position on exam table 5. Place patient in supine position with index knee flexed 10-45° 6. Apply a pneumatic, single cuff tourniquet to the mid-thigh – do not inflate. Note: this step is EXCLUDED for subjects 9-16. 7. Prep skin of target area with room temperature 10%(povidone-iodine) betadine 8. Place sterile towel over knee and position ice pack(s) over injection sites, by folding each pack in half and securing with medical tape, for approximately 20 minutes. Use ice pack provided by the Sponsor only. Note: this step is EXCLUDED for subjects 9-16. 9. Remove ice pack(s) and reapply 10% (povidone-iodine) butadiene to the skin of the target area. 10. Anesthetize the skin and soft tissues (within region of each injection site) with 1-2mL of 1% lidocaine 11.Identify the anatomical landmarks of the superomedial, superolateral, and inferomedial genicular nerves of the index knee under ultrasound or fluoroscopic imaging. The following instructions can be utilized for fluoroscopic imaging: • Superomedial Genicular Nerve 1. AP Fluoroscopic View: Needle positioned 1-2cm medial to femoral shaft – confluence of medial femoral shaft and medial epicondyle. Needle advanced until it touches the bone. 2. Lateral Fluoroscopic View: Needle repositioned so tip is positioned half-way across the diameter of the femoral shaft, withdrawn 4mm superficial to periosteum. • Superolateral Genicular Nerve 1. AP Fluoroscopic View: Needle positioned 1-2cm lateral to femoral shaft – confluence of lateral femoral shaft and lateral epicondyle. Needle advanced until it touches the bone. 2. Lateral Fluoroscopic View: Needle repositioned so tip is positioned half-way across the diameter of the femoral shaft, withdrawn 4mm superficial to periosteum. • Inferomedial Genicular Nerve 1. AP Fluoroscopic View: Needle is positioned 2-3cm medial and 3-4cm inferior to tibial shaft – confluence of medial tibial shaft and tibial flare. Needle advanced until it touches the bone. 2. Lateral Fluoroscopic View: Needle repositioned so tip is positioned at the mid-point of the diameter of tibial shaft and withdrawn 4mm superficial to periosteum. 12. Physician to position three 17-gauge, 50-mm, regular bevel needles at the appropriate locations. Note: Use injection needles provided by the Sponsor. 13. Remove stylets from needles and check for blood (if applicable) 14. Inflate tourniquet 50-100mmHg above patient’s systolic blood pressure. Note: this step is EXCLUDED for subjects 9-16. 15. Assistant of physician to retrieve one BXT-786 Syringe from freezer and place into BXT-786 Dock. Note: it is important to immediately transfer Syringe from freezer to Dock – do not leave the Syringe sitting out. 16. BXT-786 Dock will prepare Syringe for approximately 1-2 minutes; wait for blinking green light to indicate that Syringe is ready for injection. Note: it is important to immediately inject Focused Cold Therapy once Syringe has completed preparation. 17. Assistant of physician to remove Syringe from Dock 18. Physician to connect Syringe to needle positioned for superomedial genicular nerve of the index knee 19. Physician to administer 20mL of BXT Focused Cold Therapy into extra-neural space of the superomedial genicular nerve. Do not rub or massage knee once injection has been administered in order to keep Coolant within target area. Discard Syringe and needle. Note: it is important to immediately inject Coolant into patient without delay after removal from the Dock. 20. Repeat steps 14-18 for superolateral genicular nerve 21. Repeat steps 14-18 for inferomedial genicular nerve 22. Deflate and remove tourniquet. Note: this step is EXCLUDED for subjects 11-15. 23. Assistant of physician to remove physician’s outer pair of gloves 24. Place adhesive bandages over injection sites 25. Move patient to recovery area for 5-15 minutes – Assistant/physician to aid patient with mobilization; may require wheelchair 26. During recovery period, physician to perform anesthesia exam, which includes motor, sensory, and vascular evaluations. Allow patient to ask questions, print post-op instructions and follow-up schedule for patient to take home 27. Discharge patient if medically stable and able to ambulate--if patient requires assistance with mobility, provide as per standard of care at institution. 28. Subjects completing the initial 12 week study follow-up period are eligible for enrollment into the Extension Study. If consented to the extension, the subject will complete a pain diary one day per week, complete the BPI weekly, and meet with the investigator monthly during their participation. In the event a subject has already completed study by time of consent for the extension study, retrospective collection of information. Addition of Extension Study because duration of pain relief seems to be longer than initial study duration (3 months).
Sponsors
Brixton Biosciences Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects meeting ALL of the following criteria will be considered eligible for clinical trial entry: 1. Age 21 to 70 of any gender 2. Average baseline pain intensity >/= 4 on Numeric Rating Scale (NRS), despite current treatment 3. A decrease of >50% from highest NRS score with diagnostic genicular nerve block 4. Meets criteria for primary, unilateral total knee arthroplasty (TKA): • Criteria 1: Severe osteoarthritis of the knee (K-L stage 3 or 4) on plain x-rays AND • Criteria 2: Failed conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) 3. Willing/able to understand informed consent form, provide written informed consent, and able to complete outcome measures • Subjects should have access to device/equipment with internet capabilities, in order to participate in telehealth visits
Exclusion criteria
Subjects meeting ANY of the following criteria will NOT be considered eligible for clinical trial entry: 1. Known allergy to any component of BXT-786 (glycerol and/or phosphate buffered saline) 2. History of cryoglobulinemia 3. History of paroxysmal cold hemoglobinuria 4. History of cold urticaria 5. History of Raynaud’s disease 6. Open and/or infected wounds at or near treatment site 7. History of significant renal or hepatic insufficiency 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, impact the integrity of the genicular nerves 10. History of arrhythmia or seizures 11. History of low blood pressure or uncontrolled high blood pressure 12. Currently on anticoagulants or antibiotics 13. Active infection 14. Currently taking >40mg of morphine equivalent daily oral dose 15. Severe psychiatric or neurological disease that prevents subject from reporting pain assessment 16. History of local tumor-related disease 17. Pre-existing lower limb neurology that, in the opinion of the Investigator, impairs assessment of safety and/or pain 18. History of systemic inflammatory conditions such as rheumatoid arthritis 19. Previous recipient of cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the knee 20. Use of hyaluronic acid, prolotherapy, autologous blood, or platelet rich plasma injections within the previous 30 days 21. Injection of corticosteroid within the previous 3 months 22. Difficulty comprehending health status/pain questionnaires 23. Subjects who may not be able to cooperate with post-injection follow-ups/regimen 24. A history of medical conditions that would hamper block or be exacerbated by block (i.e. medical conditions requiring blood thinners; poorly managed diabetes/diabetic neuropathy; alcohol or drug addiction, COPD; etc.) 25. Known contraindication to use of a regional block 26. Pregnant/breastfeeding persons 27. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data 28. Participation in any clinical study of an investigational product within 30 days prior to enrollment and through completion of study participation 29. No scheduled surgeries until all study visits are completed (3 months)
Outcome results
None listed