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临床试验/NCT07090057
NCT07090057招募中不适用

The Effect of Targeting the Plantaris Muscle-tendon Unit in Surgical Correction of Ankle Equinus in Children

University of Alberta2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
Maximum passive ankle dorsiflexion

研究概览

简要总结

Tight ankle muscles can produce ankle equinus (limited ability to pull the foot upward) and occur often in children, significantly impacting their ability to walk. If not treated, children with ankle equinus frequently experience reduced function and long-term foot problems, such as pain. Currently, treatment options include surgery or Botulinum toxin (BoNTA) injection into the large calf muscles that point the foot downwards, aiming to reduce their tightness. However, these treatments can be less effective over time, can create prolonged calf weakness, and may require long-term bracing. Another small muscle in the leg, the plantaris, is believed to have some contribution to equinus in many children. It is sometimes included in treatment plans for equinus but its contribution is poorly understood. It is unclear whether targeting the plantaris alone could lead to better treatment of ankle equinus. Understanding the effect of treatments targeting the plantaris could help clinicians improve the management of ankle equinus.

In this study, the investigators will look at the impact of surgical treatment to the plantaris in ankle equinus. The investigators hypothesize that the plantaris is a significant contributor to equinus.

In this study, data will be collected from children undergoing surgical correction of ankle equinus, including lengthening of the plantaris and lengthening of the larger muscles producing equinus (the gastrocsoleus mechanism). Children will be randomly assigned to have either their plantaris or the gastrocsoleus lengthening be done first during surgery. All children will have both structures lengthened during surgery, only the order will be varied and all surgical procedures for each patient will be completed in a single setting. In both groups, maximum passive ankle dorsiflexion (upwards bend of the ankle with the knee straight) will be measured before and after each structure is lengthened. The outcome is maximum passive ankle dorsiflexion (upwards bend of the ankle) with the knee straight.

The investigators expect that maximum passive ankle dorsiflexion will increase after lengthening of the plantaris. Understanding the contribution of the plantaris muscle in ankle equinus could lead to significant improvements in the treatment of children with tight ankles.

详细描述

Children demonstrating equinus gait, characterized as <10° of ankle dorsiflexion relative to the leg, are commonly referred for specialist assessment. Equinus gait or deformity can occur in isolation (e.g. idiopathic toe-walking), with other foot deformities (e.g. clubfoot), or with underlying neuromotor conditions (e.g. cerebral palsy). A 2019 study found 83.3% of patients surveyed with cerebral palsy had equinus.

In children with underlying spasticity and no significant contracture, chemodenervation via Botulinum toxin (BoNTA) injections of the gastroc-soleus (GS) complex is often used to maintain functional range and optimize gait. Typically, injections become less effective over time, often leading to equinus contracture, functional impairment, and the need for orthoses or surgery. Once surgical intervention (i.e. tendoachilles (TA) lengthening or gastrocnemius (GN) recession) is required, contracture of the plantaris muscle has also been noted, usually requiring concomitant or later lengthening via tenotomy. Surgical GS lengthenings to treat ankle equinus can result in prolonged and sometimes incomplete recovery of ankle plantarflexion strength despite intensive physiotherapy, adversely affecting gait and lower limb function.

The presence and course of plantaris are believed to be variable. Recent evidence indicates that it is present in 98-100% of the population while historical estimates ranged from 80-93%. Historically considered a vestigial structure with no significant functional impact, more recently, plantaris contraction is considered to impact knee flexion and ankle plantarflexion as well as possibly contribute to external rotation of the lower leg and hindfoot inversion, similar to the GN. Given these potential functional similarities and empiric intra-operative observations of improved ankle dorsiflexion with plantaris lengthening in addition to GS complex lengthening, a plantaris tenotomy is often performed during surgery for equinus contracture. However, clinical recognition of the plantaris contribution to equinus gait and/or contracture remains inconsistent, and the effect of treatments targeting the plantaris are not well described in the literature.

The overall goal of this proposed study is to examine the contribution of the plantaris to ankle equinus by assessing the short-term impact of surgical treatment targeting the plantaris muscle-tendon unit to manage children with equinus gait and/or contracture.

The trial will compare changes to passive ankle dorsiflexion after plantaris tenotomy performed either a) before TA lengthening or GN recession or b) after TA lengthening or GN recession (in a single surgical encounter).

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
None

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • (All of the following criteria must be met):
  • Ability to provided informed consent/assent in English.
  • Pediatric patients (4-17 years) who have consented for surgery for the management of equinus contracture * (either TA lengthening or GN recession) at the Stollery Children's Hospital
  • Known underlying diagnosis of any of the following: idiopathic toe walking, cerebral palsy, hereditary spastic paraparesis, traumatic brain injury, spinal cord injury/tethering, hereditary sensory-motor neuropathy, stroke
  • Ability to maintain hindfoot and midfoot neutral during assessment
  • Passive plantarflexion on affected side greater than 20° and greater than degree of equinus contracture.
  • Note: may be isolated or in conjunction with other orthopaedic procedures; in bilateral ankle equinus procedures, data will be collected bilaterally, but included as a single participant (i.e., single randomization).

排除标准

  • (Any one or more of the following):
  • Unable to provide informed consent/assent in English.
  • Previous surgery for equinus
  • Limb deficiency on affected side
  • Knee flexion contracture of greater than 5°
  • Surgical intervention of the lower extremities below the affected knee in the last twelve months
  • BoNTA injections below the affected knee within the last six months
  • Known or suspected arthrofibrosis.

研究组 & 干预措施

Tendoachilles (TA) lengthening or gastrocnemius (GN) recession, then Plantaris tenotomy

Experimental

Participants undergo Tendoachilles (TA) lengthening or gastrocnemius (GN) recession surgery before Plantaris tenotomy.

干预措施: Tendoachilles (TA) lengthening or gastrocnemius (GN) recession, then Plantaris tenotomy (Procedure)

Plantaris tenotomy, then Tendoachilles (TA) lengthening or gastrocnemius (GN) recession

Experimental

Participants undergo Plantaris tenotomy surgery before Tendoachilles (TA) lengthening or gastrocnemius (GN) recession.

干预措施: Plantaris tenotomy, then Tendoachilles (TA) lengthening or gastrocnemius (GN) recession (Procedure)

结局指标

主要结局

Maximum passive ankle dorsiflexion

时间窗: After division of second tendon/aponeurosis

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Maximum passive ankle dorsiflexion

时间窗: Prior to skin incision

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Maximum passive ankle dorsiflexion

时间窗: Prior to division of first tendon/aponeurosis

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Maximum passive ankle dorsiflexion

时间窗: After division of first tendon/aponeurosis

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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