Targeted Muscle Reinnervation (TMR) Versus Regenerative Peripheral Nerve Interfaces (RPNI) Versus the Combined Technique of TMR-RPNI to Reduce Chronic and Phantom Limb Pain in Oncologic Amputees: A Randomized Control Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
This clinical trial evaluates two surgical techniques (targeted muscle re-innervation [TMR] and regenerative peripheral nerve interfaces [RPNI]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.
详细描述
PRIMARY OBJECTIVE:
Determine the relative effectiveness of three surgical techniques, TMR, RPNI, and TMR with RPNI, on chronic and phantom limb pain in the oncologic amputee using the validated Numerical Rating Scale (NRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) Behavior, Intensity, Interference, and Global Health Forms.
SECONDARY OBJECTIVES:
I. To estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques.
II. To estimate the rate of prosthetic use among oncologic amputees. III. To compare NRS and PROMIS among three surgical techniques to calculate the effect size and project the sample size which will be used to plan a multi-institutional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons
- •Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue
- •Patients able to complete informed consent
排除标准
- •Patients under 18 years of age
- •Patients unable to give consent
- •Patients receiving an amputation for non-oncologic purposes
- •Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect
- •Patients with multiple limb amputations
- •Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)
研究组 & 干预措施
Arm 1 (targeted muscle reinnervation)
Patients undergo TMR procedure.
干预措施: Questionnaire Administration (Other)
Arm 2 (regenerative peripheral nerve interface)
Patients undergo RPNI procedure.
干预措施: Questionnaire Administration (Other)
Arm 2 (regenerative peripheral nerve interface)
Patients undergo RPNI procedure.
干预措施: Regenerative Peripheral Nerve Interface Surgery (Procedure)
Arm 3 (TMI + RPNI)
Patients undergo TMR in combination with RPNI.
干预措施: Questionnaire Administration (Other)
Arm 3 (TMI + RPNI)
Patients undergo TMR in combination with RPNI.
干预措施: Regenerative Peripheral Nerve Interface Surgery (Procedure)
Arm 3 (TMI + RPNI)
Patients undergo TMR in combination with RPNI.
干预措施: Targeted Muscle Reinnervation (Procedure)
Arm 1 (targeted muscle reinnervation)
Patients undergo TMR procedure.
干预措施: Targeted Muscle Reinnervation (Procedure)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点