Clinical Trial: Instep Plantar Fasciotomy With and Without Gastrocnemius Recession

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: OhioHealth

Current Primary Outcome: 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.


Original Primary Outcome: 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.


Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: OhioHealth

Dates:
Date Received: October 7, 2014
Date Started: May 2014
Date Completion:
Last Updated: March 28, 2016
Last Verified: March 2016