Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Study Overview
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Brief Summary
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Compare results of Instep Plantar Fascial release with and without gastrocnemius recession

Detailed Description
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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.

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

Conditions
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Plantar Fasciitis, Equinus Deformity

Intervention / Treatment
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* Procedure: Instep without gastrocnemius recession
* Procedure: Instep with gastrocnemius recession


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Instep without Gastrocnemius Recession<br>Patient will receive an instep plantar fascial release but not a gastrocnemius recession. | Procedure: Instep without gastrocnemius recession<br>* Patient will receive an instep plantar fascial release without gastrocnemius recession.<br>|
| Experimental: Instep with Gastrocnemius Recession<br>Patient will receive an instep plantar fascial release as well as a gastrocnemius recession. | Procedure: Instep with gastrocnemius recession<br>* Patient will receive an instep plantar fascial release as well as gastrocnemius recession.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in American Orthopedic Foot and Ankle Society Score | Subjective and objective measurements which scale a patients' pain and function collected at selected intervals and compared to pre-operatively. | change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjunctive treatment | Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention | One year | 
| Complications | 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 | One year | 
| Change in Activity level | A patient submitted survey regarding their activity level and ability to perform those activities pain free. | change from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year | 
| Change Pain level | Patients will be asked to submit their pain level utilizing the Visual Analog Scale | change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Instep plantar fasciotomy