An interventional study of Instep without gastrocnemius recession and Instep with gastrocnemius recession in Plantar Fasciitis and Equinus Deformity, sponsored by OhioHealth. Withdrawn at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-29.
Sponsored by OhioHealth · Not applicable, Interventional, and Treatment
Compare results of Instep Plantar Fascial release with and without gastrocnemius recession
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.
223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.
Browse Fasciitis, Plantar studies →OhioHealth is the lead sponsor of 25 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 as well as a gastrocnemius recession.
Procedure: Instep with gastrocnemius recession
Patient will receive an instep plantar fascial release without gastrocnemius recession.
Patient will receive an instep plantar fascial release as well as gastrocnemius recession.
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.
Time frame: change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year
Adjunctive treatment
Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
Time frame: One year
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
Time frame: One year
Change in Activity level
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
Change Pain level
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
This study is withdrawn, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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