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临床试验/NCT02287714
NCT02287714撤回不适用

Surgical Treatment of Plantar Fasciitis: Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

OhioHealth4 个研究点 分布在 1 个国家开始时间: 2014年5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
撤回
发起方
OhioHealth
试验地点
4
主要终点
Change in American Orthopedic Foot and Ankle Society Score

研究概览

简要总结

Compare results of Instep Plantar Fascial release with and without gastrocnemius recession

详细描述

Plantar fasciitis is one of the most common causes of heel pain. Approximately 2 million Americans seek treatment for plantar fasciitis every year, with 10% of the population developing plantar fasciitis over a lifetime. The vast majority of cases respond to conservative care; however, the 5-10% of cases that are recalcitrant to conservative measures may require surgical intervention. Several surgical options do exist and are cited in the literature for treatment of recalcitrant plantar fasciitis. One such approach is the instep plantar fascial release, utilizing an approximately 2-3 cm plantar incision over the prominent fascial band, just distal to the fat pad of the heel. It has been demonstrated that many patients with plantar fasciitis also have an isolated contracture of the gastrocnemius, known as gastrocnemius equinus. Gastrocnemius recession is performed to correct an isolated gastrocnemius contracture and recent studies have demonstrated its successful use in the treatment of recalcitrant foot pain. To date, no prospective studies exist examining the utilization of the gastrocnemius recession in combination with instep plantar fascial release in the treatment of recalcitrant plantar fasciitis. This prospective randomized trial will aim to compare the use of instep plantar fasciotomy both with and without gastrocnemius recession in the treatment of plantar fasciitis.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients that have failed conservative treatment for greater than 6 months.
  • •Patients with recalcitrant plantar fasciitis and simultaneous gastrocnemius contracture in the ipsilateral limb. Contracture will be defined as the inability to dorsiflex the ankle past neutral with the knee in extension.

排除标准

  • •Adjunctive procedure at the time of surgery.
  • •History of heel spur surgery, plantar fasciotomy or extracorporeal shockwave therapy.

研究组 & 干预措施

Instep without Gastrocnemius Recession

Active Comparator

Patient will receive an instep plantar fascial release but not a gastrocnemius recession.

干预措施: Instep without gastrocnemius recession (Procedure)

Instep with Gastrocnemius Recession

Experimental

Patient will receive an instep plantar fascial release as well as a gastrocnemius recession.

干预措施: Instep with gastrocnemius recession (Procedure)

结局指标

主要结局

Change in American Orthopedic Foot and Ankle Society Score

时间窗: change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year

Subjective and objective measurements which scale a patients' pain and function collected at selected intervals and compared to pre-operatively.

次要结局

  • Complications(One year)
  • Adjunctive treatment(One year)
  • Change in Activity level(change from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year)
  • Change Pain level(change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year)

研究者

发起方
OhioHealth
申办方类型
Other
责任方
Sponsor

研究点 (4)

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