A Post-Market, Prospective Study to Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Average Daily Pain (ADP) Intensity Scores
研究概览
简要总结
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN, AFCN and LFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction
详细描述
The most commonly reconstructed ligament in the knee is the anterior cruciate ligament (ACL). In 2006 a total of 134,421 ACL reconstructions were performed in the United States, representing a 37% increase in procedures since 19941. Today, most ACL reconstructions are performed on an outpatient basis. While this has led to improvements in patient satisfaction and cost, it has simultaneously resulted in more complicated postoperative pain management. Managing this pain via multi-modal strategies, including peripheral nerve blocks, in the postoperative phase has been shown to decrease opioid related side effects, decrease hospital stay, and increase time to ambulation. Nursing, hospital, and pharmacy utilization in managing PCA, continuous regional nerve blocks, and administration of oral opioid dosing are associated with higher costs of care and introduce sources for staff error. Furthermore, the idea of multi-modal pain management extends beyond the surgical procedure. Decreasing prescription opioid use during outpatient rehabilitation decreases NSAID and opioid related side effects.
Myoscience, Inc. (Fremont, CA) has developed a device - iovera° - as a novel, minimally-invasive procedure using cold to target sensory nerve tissue and provide temporary pain relief through cryoneurolysis. The iovera° device uses well-established principles of cryobiology to temporarily deactivate sensory nerves that contribute to pain. Prior studies of the iovera° device have provided evidence of effectiveness and safety for treatment of the Infrapatellar Branch of the Saphenous Nerve and another study has demonstrated that a short-term block of this nerve resulted in reduced pain following an ACL reconstruction.
In a multicenter, double-blind, sham-controlled, randomized trial sponsored by Myoscience, Inc, the iovera° device was shown to temporarily relieve pain in patients with osteoarthritis of the knee. Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (p=0.0004), Day 60 (p=0.0176), and Day 90 (p=0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device- or procedure-related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse events.
The goal of the study described herein is to determine the safety and efficacy of the iovera° treatment for reducing the pain associated with anterior cruciate ligament (ACL) reconstruction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years of age
- •Scheduled to undergo unilateral anterior cruciate ligament reconstruction with patellar tendon autograft quadricep tendon autograft or hamstring tendon autograft
- •In the opinion of the investigator, the subject is an active participant in recreational or competitive sports, physical activity, or other fitness regimen at the time of ACL injury and is seeking reconstruction to help return to sport or activity
- •Subject is willing and able to give written informed consent.
- •Subject is fluent in verbal and written English.
- •Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
- •Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation.
排除标准
- •Chronic opioid use (defined as daily or almost daily use of opioids for >3 months).
- •Prior ligamentous injury and/or surgery of the operative knee (arthroscopic surgeries allowed) or relevant musculoskeletal impairment
- •Prior surgery or injury in the knee or treatment areas that may have altered the anatomy of the target nerves or resulted in scar tissue in the iovera° treatment areas.
- •Any pain disorder, neuro-muscular disorder, or neuropathy that in the opinion of the Investigator may confound post-operative assessments for pain or rehabilitation. Examples include but are not limited to: fibromyalgia, diabetic neuropathy, multiple sclerosis, etc.
- •History of opioid or alcohol abuse within past 3 years and/or active opioid user for other medical conditions.
- •Open and/or infected wound in the treatment areas or any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes.
- •History of cryoglobulinemia
- •History of paroxysmal cold hemoglobinuria.
- •History of cold urticaria.
- •History of Raynaud's disease.
- •Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
- •Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or Subject safety.
- •For any reason, in the opinion of the Investigator, the Subject may not be a suitable candidate for study participation (i.e., worker's compensation, history of noncompliance, drug dependency, etc.).
研究组 & 干预措施
Standard of Care
Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded.
Standard of Care + iovera° Treatment
The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded.
Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events.
Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded.
Local Infiltration Analgesia - 20cc 0.5% ropivicaine only
干预措施: iovera° (Device)
结局指标
主要结局
Average Daily Pain (ADP) Intensity Scores
时间窗: Baseline to 10 days post-surgery
The primary endpoint is the change from baseline to 10 days post-surgery in mean Average Daily Pain (ADP) Intensity Scores for iovera patients compared to standard of care. Trial success is demonstrated under the primary hypothesis if the p-value corresponding to the study t-test for the effect of iovera compared to the standard of care group from baseline is less than or equal to 0.05.
Pill Count
时间窗: Baseline to 12 Week
Amount of pills taken - medications to be recorded include prescription opioids. The investigator, or their designee, will then count the number of pills remaining in the bottle, record this amount and return the pills to the Subject.
次要结局
- Single Assessment Numerical Evaluation (SANE) Score(Baseline to 12 Week)
- Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)(Baseline to 12 Week)
- Area-Under-Effect (AUE) curves(Baseline to 12 Week)