Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Sponsor

OhioHealth (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02287714

Collaborator

(none)

Enrollment

Locations

Arms

21.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Plantar Fasciitis Equinus Deformity	Procedure: Instep without gastrocnemius recession Procedure: Instep with gastrocnemius recession	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Instep without Gastrocnemius Recession Patient will receive an instep plantar fascial release but not a gastrocnemius recession.	Procedure: Instep without gastrocnemius recession Patient will receive an instep plantar fascial release without gastrocnemius recession.
Experimental: Instep with Gastrocnemius Recession Patient will receive an instep plantar fascial release as well as a gastrocnemius recession.	Procedure: Instep with gastrocnemius recession Patient will receive an instep plantar fascial release as well as gastrocnemius recession.

Arm

Intervention/Treatment

Active Comparator: Instep without Gastrocnemius Recession

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

Procedure: Instep without gastrocnemius recession

Patient will receive an instep plantar fascial release without gastrocnemius recession.

Experimental: Instep with Gastrocnemius Recession

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

Procedure: Instep with gastrocnemius recession

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

Outcome Measures

Primary Outcome Measures

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

Adjunctive treatment [One year]
Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Step Lively Foot and Ankle Center	Dublin	Ohio	United States	43016
2	Foot and Ankle Specialists of Central Ohio	Gahanna	Ohio	United States	43230
3	Step Lively Foot and Ankle Center	Grove City	Ohio	United States	43123
4	Step Lively Foot and Ankle Center	Reynoldsburg	Ohio	United States	43068