Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Not Applicable

Withdrawn

• Conditions: Plantar Fasciitis; Equinus Deformity
• Interventions: Procedure: Instep without gastrocnemius recession; Procedure: Instep with gastrocnemius recession

• Registration Number: NCT02287714
• Lead Sponsor: OhioHealth

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instep without Gastrocnemius Recession	Instep without gastrocnemius recession	Patient will receive an instep plantar fascial release but not a gastrocnemius recession.
Instep with Gastrocnemius Recession	Instep with gastrocnemius recession	Patient will receive an instep plantar fascial release as well as a gastrocnemius recession.

Primary Outcome Measures

Name	Time	Method
Change in American Orthopedic Foot and Ankle Society Score	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.

Secondary Outcome Measures

Name	Time	Method
Complications	One year	Participant chart will be reviewed for any complications that occurred during their one year follow-up, including but not limited to: Recurrence of symptoms, no improvement, infection, tear or rupture of plantar fascia following procedure
Adjunctive treatment	One year	Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
Change in Activity level	change from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year	A patient submitted survey regarding their activity level and ability to perform those activities pain free.
Change Pain level	change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year	Patients will be asked to submit their pain level utilizing the Visual Analog Scale

Trial Locations

Locations (2)

Step Lively Foot and Ankle Center; 🇺🇸 Reynoldsburg, Ohio, United States

Foot and Ankle Specialists of Central Ohio; 🇺🇸 Gahanna, Ohio, United States