Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

NCT ID: NCT02287714

Last Updated: 2016-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-02-29

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.

Conditions

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Plantar Fasciitis Equinus Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Instep without Gastrocnemius Recession

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

Group Type ACTIVE_COMPARATOR

Instep without gastrocnemius recession

Intervention Type PROCEDURE

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 a gastrocnemius recession.

Group Type EXPERIMENTAL

Instep with gastrocnemius recession

Intervention Type PROCEDURE

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

Interventions

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Instep without gastrocnemius recession

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

Intervention Type PROCEDURE

Instep with gastrocnemius recession

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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OhioHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda Quisno, DPM

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

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Step Lively Foot and Ankle Center

Dublin, Ohio, United States

Site Status

Foot and Ankle Specialists of Central Ohio

Gahanna, Ohio, United States

Site Status

Step Lively Foot and Ankle Center

Grove City, Ohio, United States

Site Status

Step Lively Foot and Ankle Center

Reynoldsburg, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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13-0043

Identifier Type: -

Identifier Source: org_study_id

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