An Initial Study for the Use of a New Cold Energy System (BXT-786) to Provide Pain Relief Through A Regional Block for Subjects with unrelieved pain related to severe osteoarthritis of the knee.

Phase 1

• Conditions: knee pain; knee replacement; Osteoarthritis (severe knee); Anaesthesiology - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12621001667808
• Lead Sponsor: Brixton Biosciences Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-03
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified