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