Clinical trial NCT02287714: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Plantar Fasciitis
Equinus Deformity
Keywords: Instep plantar fasciotomy
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in American Orthopedic Foot and Ankle Society Score
timeFrame: change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year
Secondary outcomes:
measure: Adjunctive treatment
timeFrame: One year
measure: Complications
timeFrame: One year
measure: Change in Activity level
timeFrame: change from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year
measure: Change Pain level
timeFrame: change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Step Lively Foot and Ankle Center
state: Ohio
city: Gahanna
country: United States
facility: Foot and Ankle Specialists of Central Ohio
state: Ohio
city: Grove City
country: United States
facility: Step Lively Foot and Ankle Center
state: Ohio
city: Reynoldsburg
country: United States
facility: Step Lively Foot and Ankle Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Amanda Quisno, DPM
role: PRINCIPAL_INVESTIGATOR
References: