Saphenous Nerve Brach Burial for Preventing Neuralgia After Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Incidence of neuralgia
研究概览
简要总结
This is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty.
详细描述
Anterior knee pain is common after total knee arthroplasty. The incision necessarily travels through the path of a cutaneous nerve - branches of the saphenous nerve. Historically, no effort has been made to separate these branches and bury them away from the surgical scar. It has been noted that some patients develop a painful neuroma, that once resected results in a pain free knee. Investigators are trying to study if identification, ligation, and proper burial of the nerve can prevent the development of neuralgia compared to the typical surgical approach which ignores the nerve branches completely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
- •Must be willing to undergo randomization
排除标准
- •Age <18 or >80 years
- •Known pre-operative diagnosis of neuralgia, complex regional pain syndrome, or neuropathy, about the operative lower extremity
- •Known pre-operative psychiatric disorder requiring medication
- •Previous surgery about the operative knee
- •BMI > 40 kg/m2 (potential increased risk of soft tissue dissection through adipose)
- •Ongoing pre-operative narcotic use in excess of 20 mg morphine equivalents per day for at least one month or pre-operative intravenous drug use (increased potential for complex regional pain syndrome and neuralgia, increased likelihood to require greater post-operative analgesia)
- •Ongoing pre-operative use of neuropathic pain medications (gabapentin, pregabalin, amitriptyline, etc.)
- •Medical comorbidities (American Society of Anesthesiologists grade > 3 or deemed unfit by consulting internist) precluding elective TKA
- •Significant language barrier (reading comprehension less than 8th grade reading level) or mental condition precluding accurate self-assessment of knee pain or function.
- •Severe medication allergies to permissible post-operative analgesics (acetaminophen, tramadol, oxycodone, oxycontin, dilaudid)
研究组 & 干预措施
Control
Standard total knee arthroplasty performed through medial parapatellar approach
干预措施: Standard total knee arthroplasty (Procedure)
Intervention
Total knee arthroplasty performed through medial parapatellar approach with identification, ligation, and burial of saphenous nerve branches
干预措施: Total knee arthroplasty with Saphenous nerve burial (Procedure)
结局指标
主要结局
Incidence of neuralgia
时间窗: 2 years
Measured by DN4 validated scoring tool
次要结局
- Oxford Knee Score(2 years)
- Kneeling weight(2 years)