Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02287714
• Other study ID #: 13-0043
• Status: Withdrawn
• Phase: N/A
• First received: October 7, 2014
• Last updated: March 28, 2016
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Procedure:
• Instep without gastrocnemius recession
Patient will receive an instep plantar fascial release without gastrocnemius recession.
• Instep with gastrocnemius recession
Patient will receive an instep plantar fascial release as well as gastrocnemius recession.

Locations

Country	Name	City	State
United States	Step Lively Foot and Ankle Center	Dublin	Ohio
United States	Foot and Ankle Specialists of Central Ohio	Gahanna	Ohio
United States	Step Lively Foot and Ankle Center	Grove City	Ohio
United States	Step Lively Foot and Ankle Center	Reynoldsburg	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adjunctive treatment	Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention	One year	No
Secondary	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	No
Secondary	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	No
Secondary	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	No