Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

March 28, 2016 updated by: OhioHealth

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Step Lively Foot and Ankle Center
      • Gahanna, Ohio, United States, 43230
        • Foot and Ankle Specialists of Central Ohio
      • Grove City, Ohio, United States, 43123
        • Step Lively Foot and Ankle Center
      • Reynoldsburg, Ohio, United States, 43068
        • Step Lively Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in American Orthopedic Foot and Ankle Society Score
Time Frame: 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.
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
Time Frame: One year
Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
One year
Complications
Time Frame: 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
One year
Change in Activity level
Time Frame: 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 from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year
Change Pain level
Time Frame: 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
change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OhioHealth

Investigators

  • Principal Investigator: Amanda Quisno, DPM, OhioHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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