Study Stopped
Low (no) enrollment.
Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
Surgical Treatment of Plantar Fasciitis: Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
1 other identifier
interventional
N/A
1 country
4
Brief Summary
Compare results of Instep Plantar Fascial release with and without gastrocnemius recession
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 29, 2016
March 1, 2016
1.8 years
October 7, 2014
March 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year
Secondary Outcomes (4)
Adjunctive treatment
One year
Complications
One year
Change in Activity level
change from baseline (within 30 days prior to intervention) activity level at 3 months, 6 months, and one year
Change Pain level
change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year
Study Arms (2)
Instep without Gastrocnemius Recession
ACTIVE COMPARATORPatient will receive an instep plantar fascial release but not a gastrocnemius recession.
Instep with Gastrocnemius Recession
EXPERIMENTALPatient will receive an instep plantar fascial release as well as a gastrocnemius recession.
Interventions
Patient will receive an instep plantar fascial release without gastrocnemius recession.
Patient will receive an instep plantar fascial release as well as gastrocnemius recession.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Adjunctive procedure at the time of surgery.
- History of heel spur surgery, plantar fasciotomy or extracorporeal shockwave therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OhioHealthlead
Study Sites (4)
Step Lively Foot and Ankle Center
Dublin, Ohio, 43016, United States
Foot and Ankle Specialists of Central Ohio
Gahanna, Ohio, 43230, United States
Step Lively Foot and Ankle Center
Grove City, Ohio, 43123, United States
Step Lively Foot and Ankle Center
Reynoldsburg, Ohio, 43068, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda Quisno, DPM
OhioHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
November 11, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 29, 2016
Record last verified: 2016-03