A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Passive ankle dorsiflexion (PDF)
研究概览
简要总结
For years, we have used a minimally invasive and biological variant of Achilles tendon lengthening using a needle inserted into the Achilles tendon so that it is weakened and can be gradually stretched to the desired length. So far, no negative effects, complications or tendon problems have been observed. A prospective study of a cohort of children and adolescents is planned where there is an indication for Achilles lengthening, such as spastic or non-spastic contracture and toe walking that results in an unwanted shortening of the Achilles tendon that makes walking difficult. We plan to include up to 50 children and adolescents over a two-year period and follow them closely for the first year after surgery. Pediatric physiotherapists will perform all clinical examinations to limit observer bias, and a radiologist will examine the tendon tissue with ultrasound before and one year after surgery to check anatomical conditions. The study will examine safety, effectiveness and feasibility of using the method, and anatomy, patient satisfaction and quality of life.
详细描述
cases of restriction. Traditionally, Achilles tendon lengthening has been performed through open surgery using Z lengthening or sliding techniques, or percutaneously with 2-3 partial cuts using a scalpel. However, these methods may lead to scarring and other complications that some find troublesome.
A novel technique for Achilles tendon lengthening involves the needle technique, which applies a series of percutaneous microtenotomies to the tendon using needle pricks. These microtenotomies gradually weaken and stretch the tendon to the desired length without necessitating the opening of the skin or tendon sheath, thus avoiding scar formation. This modified technique may offer potential advantages over traditional methods, yet there is limited research in this area. It is also unknown how the Achilles tendon reorganizes anatomically following needle lengthening. The technique is similar to that used in the percutaneous release of Dupuytren's contracture, and several reports have emerged on the use of this method for Achilles tenotomy in the treatment of clubfoot. Ultrasound-guided needle techniques for gastrocnemius recession have also been reported. We have utilized this technique in approximately 200 patients over the past few years with positive experiences, both in terms of surgical technique and clinical outcomes. Patients predominantly report positive experiences with significant benefits from the lengthening.
The purpose of this study is to evaluate the needle technique as a surgical method for Achilles tendon lengthening in children and adolescents. The study will assess the efficacy, feasibility, and safety of the percutaneous needle technique for Achilles tendon lengthening in pediatric patients. The study aims to contribute to the knowledge of a new and likely more benign surgical method for treating equinus foot deformities in children and to evaluate whether the needle technique can be a safe, effective, and feasible alternative to existing treatments.
Objective:
To compare the efficacy and safety of two surgical techniques (needle technique vs. standard Z-plasty) for Achilles tendon lengthening in pediatric patients aged ≥ 5 to ≤ 16 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 5-16 years
- •Consent from parents/guardians
- •Indication for Achilles tendon lengthening (toe walking, spasticity), both unilateral and bilateral:
- •Equinus foot with dorsiflexion ≤ 0 degrees with the knee extended and the heel in neutral position.
- •Symptomatic equinus foot, meaning a foot position causing pain, discomfort, increased fatigue, etc.
排除标准
- •Unwillingness to participate, lack of consent
- •Previous surgical Achilles tendon lengthening, e.g., for clubfoot
- •Received BoNT-a injection in the triceps surae within the last 6 months
- •Contracture in the ankle joint, i.e., equinus position not due to a tight Achilles tendon
- •Positive Silfverskiöld test and dorsiflexion > 5 degrees with the knee extended (indicating the need for gastrocnemius recession)
- •Concurrent other surgery/other procedures on the same lower extremity, including BoNT-a injection
结局指标
主要结局
Passive ankle dorsiflexion (PDF)
时间窗: Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after the surgery.
Passive ankle dorsiflexion (PDF) (degrees) lying down with an extended knee using a goniometer. The examination is performed by experienced physiotherapists that are not involved in the project.
次要结局
- Passive ankle dorsiflexion (PDF)(Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after surgery.)
- Active ankle dorsiflexion (ADF)(Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after the surgery.)
- Plantar flexion strength(Baseline, as measured preoperatively, then after 6 months, and one year after the surgery.)
- Complications and adverse events(At follow-up check-ups after 4 weeks, 6 months, and one year after the surgery.)