Plantar FasciitisNCT02287714
Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
A study testing Instep without gastrocnemius recession and Instep with gastrocnemius recession in people with Plantar Fasciitis and Equinus Deformity, run by OhioHealth at 4 sites in United States.
Trial summary
Compare results of Instep Plantar Fascial release with and without gastrocnemius recession Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Equinus Deformity
- What is being tested?
- Instep without gastrocnemius recession and Instep with gastrocnemius recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Adjunctive procedure at the time of surgery.
- History of heel spur surgery, plantar fasciotomy or extracorporeal shockwave therapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Step Lively Foot and Ankle Center
Dublin, Ohio, 43016
Foot and Ankle Specialists of Central Ohio
Gahanna, Ohio, 43230
Step Lively Foot and Ankle Center
Grove City, Ohio, 43123
Step Lively Foot and Ankle Center
Reynoldsburg, Ohio, 43068
About this study
Official title: Surgical Treatment of Plantar Fasciitis: Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
Compare results of Instep Plantar Fascial release with and without gastrocnemius recession
Read the 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.
- Conditions
- Plantar Fasciitis, Equinus Deformity
- Being tested
- Instep without gastrocnemius recession, Instep with gastrocnemius recession
- Keywords
- Instep plantar fasciotomy
- Medical subject headings
- Fasciitis, Plantar, Equinus Deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instep without gastrocnemius recessionProcedure or surgery
Patient will receive an instep plantar fascial release without gastrocnemius recession.
Instep with gastrocnemius recessionProcedure or surgery
Patient will receive an instep plantar fascial release as well as gastrocnemius recession.
| Study group | Role | What they receive |
|---|---|---|
| Instep without Gastrocnemius Recession | Active comparator | Patient will receive an instep plantar fascial release but not a gastrocnemius recession. Receives: Procedure: Instep without gastrocnemius recession |
| Instep with Gastrocnemius Recession | Experimental | Patient will receive an instep plantar fascial release as well as a gastrocnemius recession. Receives: Procedure: Instep with gastrocnemius recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline (within 30 days prior to intervention) AOFAS score at 3 mo, 6 mo, and one year
Secondary outcomes (4)
Adjunctive treatment
Participant chart will be reviewed for any adjunctive treatment required following their surgical intervention
Measured: 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
Measured: One year
Change in Activity level
A patient submitted survey regarding their activity level and ability to perform those activities pain free.
Measured: 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
Measured: change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Low (no) enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Quisno, DPM, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287714
- Sponsor's protocol ID
- 13-0043
- Status last verified
- Mar 2016
- First submitted
- 7 Oct 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Plantar Fasciitis: Instep Plantar Fasciotomy With and Without Gastrocnemius Recession
- ClinicalTrials.gov ID
- NCT02287714
- Acronym / sponsor ID
- 13-0043
- Conditions
- Plantar Fasciitis, Equinus Deformity
- Keywords
- Instep plantar fasciotomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low (no) enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instep without Gastrocnemius Recession | Active comparator | Procedure: Instep without gastrocnemius recessionPatient will receive an instep plantar fascial release but not a gastrocnemius recession. |
| Instep with Gastrocnemius Recession | Experimental | Procedure: Instep with gastrocnemius recessionPatient will receive an instep plantar fascial release as well as a gastrocnemius recession. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Adjunctive procedure at the time of surgery.
- History of heel spur surgery, plantar fasciotomy or extracorporeal shockwave therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instep without gastrocnemius recessionPatient will receive an instep plantar fascial release without gastrocnemius recession. | Procedure or surgery | Instep without Gastrocnemius Recession |
| Instep with gastrocnemius recessionPatient will receive an instep plantar fascial release as well as gastrocnemius recession. | Procedure or surgery | Instep with Gastrocnemius Recession |
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.
4 secondary outcomes
Adjunctive treatment
Time frame: One year
Complications
Time frame: One year
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
Change Pain level
Time frame: change from baseline (within 30 days prior to intervention) pain level at 3 months, 6 months, and one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
Related trials for Plantar Fasciitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Recruiting
Extracorporeal Shock Wave Therapy With or Without Kinesiotaping for Plantar Fasciitis
Plantar Fasciitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Quisno, DPM principal investigator
OhioHealth
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instep without gastrocnemius recession and Instep with gastrocnemius recession in people with Plantar Fasciitis and Equinus Deformity, run by OhioHealth at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.