Prevention of PostAmputation Pain With Targeted Muscle Reinnervation: A National, Multicenter, Randomized, Sham-controlled Superiority Trial, Comparing Standard Neurectomy With Targeted Muscle Reinnervation in Amputations of the Lower Extremities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 203
- 试验地点
- 14
- 主要终点
- Postoperative residual limb pain
研究概览
简要总结
The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy) versus those who received Targeted Muscle Reinnervation (TMR).
Patients between 18 and 75 years old, scheduled for an LEA (transfemoral to transtibial) as a primary or secondary sequela of vascular disease, are randomized into standard neurectomy or TMR. TMR is a frequently studied surgical technique and prevents neuroma formation by rerouting a cut mixed nerve end to a functional motor nerve.
The investigators hypothesize that TMR during amputation surgery will significant improve PostAmputation Pain (PAP), quality of life, participation in family life and society, and reduction of health-related costs. Participants will be asked to complete multiple online questionnaires postoperatively regarding these outcomes at five evaluation moments (at 2 weeks, and at 3, 6, 9, and 12 months).
详细描述
Rationale: In the Netherlands, approximately 3300 lower extremity amputations (sacroiliac to forefoot) are performed each year. In current amputation practice, the nerves are simply cut, without employing any nerve surgical techniques to prevent the development of chronic pain due to neuroma formation. Around 61% of these patients develop postamputation pain (PAP). PAP is a severe lifelong disabling condition profoundly affecting quality of life.
Microsurgical nerve handling can prevent the formation of a painful neuroma and its sequelae. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique with promising results. TMR prevents neuroma formation by rerouting a cut mixed nerve end to a functional motor nerve.
The expected benefit of the implementation of TMR during amputation surgery is a significant reduction in the incidence of PAP. Prevention of this chronic pain syndrome will lead to a significant improvement in quality of life, participation in family life and society, and reduction of health-related costs for thousands of amputation patients every year. To achieve this, a transformation of nerve handling during amputation is needed.
Objective: To compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy) versus those who received TMR.
Study design: A national, multicenter, randomized, sham-controlled superiority trial, comparing standard neurectomy with TMR in amputations of the lower extremities.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years old.
- •Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease.
排除标准
- •Insensate limbs at the level of amputation.
- •Complex Regional Pain Syndrome.
- •Existing neuroma or prior neuroma surgery in the affected limb.
- •Undergoing radiotherapy on the affected limb.
- •Cognitive impairment, or delirium at the time of consent.
- •Patients who are unfit for general anesthesia.
- •No nerve surgeon trained in the TMR procedure is available
结局指标
主要结局
Postoperative residual limb pain
时间窗: at 12 months
Postoperative residual limb pain will be scored on the 11-point (0-10) Numeric Rating Scale (NRS) for 30 consecutive days in a pain diary. A higher score indicates more pain.
Postoperative phantom limb pain
时间窗: at 12 months
Postoperative phantom limb pain will be scored on the 11-point (0-10) Numeric Rating Scale (NRS) for 30 consecutive days in a pain diary. A higher score indicates more pain.
Postoperative pain behavior
时间窗: at 12 months
Postoperative pain behavior will be scored using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior Short Form 7a. The results will be scored on a scale from 7 to 35 points, with a higher score indicating that pain has a greater influence on behavior.
Postoperative pain interference
时间窗: at 12 months
Postoperative pain interference will be scored using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a. The results will be scored on a scale from 8 to 40 points, where a higher score indicates greater interference of pain with daily life
次要结局
- Postoperative residual limb pain(at 3, 6, and 9 months)
- Postoperative phantom limb pain(at 3, 6, and 9 months)
- Postoperative pain behavior(at 3, 6, and 9 months)
- Postoperative pain interference(at 3, 6, and 9 months)
- Neuropathic pain(at 12 months)
- Hospital anxiety(at 12 months)
- Depression(at 12 months)
- Global perceived effect(at 12 months)
- Prosthetic rehabilitation(at 12 months)
- EuroQol-5D-5L(at 2 weeks, and at 3, 6, 9 and 12 months)
- Medical consumption costs(at 3, 6, 9, and 12 months)
- Productivity costs(at 3, 6, 9, and 12 months)
- Budget impact analysis (BIA).(at 12 months)
- Pain medication use(at 3, 6, 9, and 12 months)
- Type of pain(at 3, 6, 9 and 12 months)
研究者
jlgroen
MD PhD
Leiden University Medical Center