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Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Primary Purpose

Plantar Fasciitis, Equinus Deformity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Instep without gastrocnemius recession
Instep with gastrocnemius recession
Sponsored by
OhioHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Instep plantar fasciotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Step Lively Foot and Ankle Center
  • Foot and Ankle Specialists of Central Ohio
  • Step Lively Foot and Ankle Center
  • Step Lively Foot and Ankle Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Instep without Gastrocnemius Recession

Instep with Gastrocnemius Recession

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adjunctive treatment
Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
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
Change in Activity level
A patient submitted survey regarding their activity level and ability to perform those activities pain free.
Change Pain level
Patients will be asked to submit their pain level utilizing the Visual Analog Scale

Full Information

First Posted
October 7, 2014
Last Updated
March 28, 2016
Sponsor
OhioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT02287714
Brief Title
Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
Official Title
Surgical Treatment of Plantar Fasciitis: Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Low (no) enrollment.
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Equinus Deformity
Keywords
Instep plantar fasciotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instep without Gastrocnemius Recession
Arm Type
Active Comparator
Arm Description
Patient will receive an instep plantar fascial release but not a gastrocnemius recession.
Arm Title
Instep with Gastrocnemius Recession
Arm Type
Experimental
Arm Description
Patient will receive an instep plantar fascial release as well as a gastrocnemius recession.
Intervention Type
Procedure
Intervention Name(s)
Instep without gastrocnemius recession
Intervention Description
Patient will receive an instep plantar fascial release without gastrocnemius recession.
Intervention Type
Procedure
Intervention Name(s)
Instep with gastrocnemius recession
Intervention Description
Patient will receive an instep plantar fascial release as well as gastrocnemius recession.
Primary Outcome Measure Information:
Title
Change in American Orthopedic Foot and Ankle Society Score
Description
Subjective and objective measurements which scale a patients' pain and function collected at selected intervals and compared to pre-operatively.
Time Frame
change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year
Secondary Outcome Measure Information:
Title
Adjunctive treatment
Description
Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
Time Frame
One year
Title
Complications
Description
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
Time Frame
One year
Title
Change in Activity level
Description
A patient submitted survey regarding their activity level and ability to perform those activities pain free.
Time Frame
change from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year
Title
Change Pain level
Description
Patients will be asked to submit their pain level utilizing the Visual Analog Scale
Time Frame
change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Quisno, DPM
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Step Lively Foot and Ankle Center
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Foot and Ankle Specialists of Central Ohio
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Step Lively Foot and Ankle Center
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Facility Name
Step Lively Foot and Ankle Center
City
Reynoldsburg
State/Province
Ohio
ZIP/Postal Code
43068
Country
United States

12. IPD Sharing Statement

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Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

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