ACTRN12621001667808尚未招募1 期
A Pilot, Non-Randomized, Open Label Study of a Novel Device and its Delivery System (BXT Focused Cold Therapy), Providing Cold Energy Regional Anesthetic Block for Knee Pain Management
Brixton Biosciences Pty Ltd0 个研究点目标入组 16 人开始时间: 2021年12月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 70 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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