NCT03912116撤回不适用
Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
Tissue Tech Inc.2 个研究点 分布在 1 个国家开始时间: 2019年4月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Difference in Pain at 2 weeks: visual analog scale
研究概览
简要总结
Total knee arthroplasty (TKA) is the most common joint replacement surgery and its incidence is expected to increase 673% to 3.48 million procedures annually by 2030. After more than 20 years of follow-up data, TKA is confirmed to be an effective treatment for knee osteoarthritis, however, postoperative pain management continues to be a challenge despite advances in surgical techniques and anesthetic practice to minimize discomfort and enhance recovery. This acute post-surgical pain caused by extensive tissue damage and inflammation in TKA leads to restricted post-operative knee range of motion (ROM) and ability to mobilize.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, greater than 18 years of age
- •Primary diagnosis of unilateral osteoarthritis of the knee
- •Scheduled to undergo primary, unilateral TKA
- •ASA physical status 1, 2, or 3
排除标准
- •Patient has concurrent painful physical condition not strictly related to the knee surgery that may require analgesic treatment (such as NSAIDs or opioid) that may confound postsurgical assessments as determined by the investigator
- •Patient on chronic daily narcotic medication for knee pain based on medical history and Florida Prescription Drug Monitoring Program (E-FORCSE)
- •Allergy or contraindication to any of the study medications
- •Patient reported renal impairment based on medical history
- •Bodyweight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
- •History of previous fracture or open surgery on the knee being considered for TKA
- •History of patellar instability, e.g., Valgus deformity
- •History of inflammatory arthropathy (e.g., Rheumatoid arthritis, Lupus, etc.)
- •Use of cryoneurolysis, or cryoanalgesia, including iovera® device (Myoscience, Fremont, CA) on the operative knee within the last 6 months or planned during study duration
- •Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might impact postsurgical pain or confound postsurgical assessments
- •Planned use of intra-articular steroid injections during the study.
- •Received any local anesthetic within 7 days of the planned TKA procedure aside from those part of the protocol
- •Planned use of potent inhalational agents or peripheral nerve block (e.g., femoral nerve block)
- •Current or planned use of neuraxial (epidural or intrathecal) opioids
- •Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
- •History of suspected, or known, misuse, abuse, dependence of opioid analgesics, illicit drugs, prescription medicines, or alcohol within the past 2 years
- •Currently pregnant, nursing, or planning to become pregnant during the study
结局指标
主要结局
Difference in Pain at 2 weeks: visual analog scale
时间窗: 2 weeks
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
次要结局
- Length of Hospital Stay(5 days)
- Difference in Pain at 5-7 days: visual analog scale(5-7 days)
- Difference in Patient Satisfaction: Questionnaire(2 weeks)
- Difference in Subjective Outcome(2 weeks)
- Difference in range of motion between baseline and 2 weeks(2 weeks)
- Difference in Quality of Life: SF-36(2 weeks)
- Difference in pain medication consumption(2 weeks)
- Difference in Number of Readmissions(2 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Acute Kidney Injury After Elective Total Joint ArthroplastyAcute Kidney InjuryNCT05595694The University of Hong Kong1,077
Unknown
不适用
Total Knee Arthroplasty Robot Assisted With MAKO™ Robotic System Compared to the Conventional Total Knee Arthroplasty by Mechanical AncillaryTotal Knee ArthroplastyNCT03566875University Hospital, Grenoble60
进行中（未招募）
不适用
Journey Bicruciate Stabilized (BCS) Design and Legion Posterior Stabilized (PS) Design; Comparative StudyPrimary Total Knee ArthroplastyNCT04855864Universitaire Ziekenhuizen KU Leuven75
已完成
不适用
Muscle Recovery After Total Knee ArthroplastyKnee Arthritis, OsteoarthritisNCT06096792Hacettepe University20
已完成
不适用
Effect of Adductor Canal Nerve Block Compared to a Simulated Block on Quadriceps Strength Following Knee ArthroplastyKnee ArthroplastyNCT02166710Centre hospitalier de l'Université de Montréal (CHUM)60