Comparative Study of Post-Operative Outcomes of the Two-Incision Carpal Tunnel Release vs Mini-Open Carpal Tunnel Release
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Resolution of carpal tunnel symptoms
研究概览
简要总结
Hand surgeons have many options to perform carpal tunnel release surgery. Some surgeons believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.
This study aims to determine whether sparing these superficial structures indeed improves patient outcomes, compared to a conventional two incision approach.
详细描述
Carpal tunnel release (CTR) is a common surgery done by hand surgeons. The aim of the procedure is to decompress the median nerve at the level of the wrist and alleviate patient symptoms that include numbness, pain and tingling sensations along the median nerve distribution. Many versions of the technique have been described, with each description claiming improvement of post-operative results and decreasing complications.
The first description of carpal tunnel release is believed to be that of Learmonth in 1933 where he describes incising the transverse carpal ligament in a lady with a wrist fracture1. Since then, the understanding towards carpal tunnel syndrome has markedly improved, and various surgical techniques have been developed.
Because carpal tunnel syndrome has become such a common condition among the population, much knowledge has been gained about carpal tunnel surgery as well. One of the easily avoided complications of the procedure is scar related morbidity and pillar pain. Bromley offered a mini-palm open carpal tunnel release technique that decompressed the median nerve while keeping the entirety of the incision distal to the wrist crease. Tsai et al and Wilson also offered two-incision open carpal tunnel release techniques in order to keep incisions small but ensure complete release both proximally and distally. Endoscopic techniques were also eventually developed with the aim of a complete release while avoiding scar related complications.
With the many options surgeons have on how to decompress the median nerve, some begin to question if techniques are being made unnecessarily complicated. Some believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.
This study aims to determine whether sparing these superficial structures indeed improves patient outcomes.
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 (Investigator)
盲法说明
Patients will be scheduled and added to the operative list of the day by the PI's primary nurse. The primary nurse is not a part of the study and will not be present in the operating room. On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique.
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
- •Participants over the age of 18
- •Patients who have not undergone any prior wrist surgery that may alter the native wrist anatomy
- •Participants surgery must only be carpal tunnel release (no trigger fingers, de quervain release, etc.)
- •Participants must have read and understood the consent form for the performance of the procedure and enrollment into the study. Consent must be signed in front of the principal investigator and a witness
排除标准
- •Patients who are under the age of 18
- •Patients who had other major surgery on the extremity being assessed potentially altering the native anatomy of the volar wrist area
- •Patients who plan to have multiple hand procedures done along with their carpal tunnel release
- •Patients refusing to sign the consent and enrollment form for the study
研究组 & 干预措施
1 incision technique
a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease.
干预措施: Mini open incision CTR (Procedure)
Two incision technique
A two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally
干预措施: Mini open incision CTR (Procedure)
结局指标
主要结局
Resolution of carpal tunnel symptoms
时间窗: Six weeks
Reporting 2 or less on the 0-10 pain scale, with 0 as no pain
次要结局
- Time to return to work(Six weeks)