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临床试验/NCT04050748
NCT04050748已完成不适用

Comparison of Tendon Lengthening With Traditional vs. Accelerated Rehab Following Achilles Tendon Repair: A Prospective Randomized Controlled Trial

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Repair site lengthening

研究概览

简要总结

The purpose of this study is to evaluate the surgically repaired tendon of a ruptured achilles tendon. We will investigate fixation slippage and tendon creep and correlate how these post-repair findings can contribute to outcomes of tendon repairs.

详细描述

pture of the Achilles tendon is a relatively common injury among athletes involved in sports which require rapid direction changes and accelerations, such as soccer, sprinting, and basketball. Approximately 80% of ruptures occur during recreational sports, but it can also occur in sedentary individuals. An increase in recreational sport involvement has coincided with an increase in Achilles tendon ruptures. The most common age group for this injury is between 30 and 40 years old, and it is more likely to occur in males. It is thought that rupture in this age group is highest due to the co-occurrence of competitive sports and age- related degenerative changes.

Tendons changes occur as we age. There is decreased collagen density and fewer cross links, which alters the integrity of the tendon and its sheath. These changes, in addition to repetitive microtrauma, can cause the Achilles tendon to become calcified and thickened. Alteration in the elasticity of the tendon can set the stage for a rupture during abrupt increases in training intensity or during competitions.

The Achilles tendon is the largest tendon in the body, and it receives its blood supply from the gastroc- soleus complex. The blood supply is weakest between 2cm and 6cm from the tendon's insertion on the calcaneus, which is also the region where it is most likely to rupture.

The current recommendation for acute Achilles rupture is surgical repair, but there is no consensus regarding surgical versus nonsurgical treatment (immobilization, rehab, etc.). Surgical repair is thought to reduce the rates of re-rupture but also cause an increased risk of complications. There does not appear to be a difference in pre-injury activity levels between the two methods.

Tendons have excellent healing potential when the torn ends are reasonably approximated. Optimal tendon healing depends on surgical apposition and mechanical stabilization of the tendon ends. Once a tendon has been repaired, the suture material holds the tendon ends together, allowing fibroblasts to produce sufficient amounts of collagen to form a tendon callus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with an acute tendon rupture less than 6 weeks were included in this study.

排除标准

  • Underwent any additional concomitant procedures or tendon transfers, sustained prior ruptures, or had a chronic rupture.

研究组 & 干预措施

Early Rehabiliation

Placebo Comparator

6 weeks of non-weight bearing in addition to basic stretching exercises.

干预措施: Achilles tendon repair (Procedure)

Accelerated Rehabilitation

Active Comparator

Patients will be non-weight bearing for 2 weeks. After 2 weeks patients were transitioned to a boot with two heel wedges and were weight bearing as tolerated. At 4 weeks, patients were transitioned to one wedge, and at 6 weeks patients were weight bearing as tolerated in a flat shoe. Each heel wedge was ¾ inch tall. After 6 weeks, patient's in both groups underwent identical rehab regimens per protocol

干预措施: Achilles tendon repair (Procedure)

结局指标

主要结局

Repair site lengthening

时间窗: 2 years

Intratendinous and repair site lengthening were determined

次要结局

  • Achilles Tendon Total Rupture Score(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Toufic R. Jildeh

Principal Investigator

Henry Ford Health System

研究点 (2)

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