- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06535724
Endoscopic Debridement of Chronic Plantar Fasciitis
Endoscopic Debridement of Chronic Plantar Fasciitis With Heel Spur Resection: a Novel Technique With Promising Outcomes - a Prospective Cohort Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Hypothesis: Conducting research on a group of patients will prove that the use of endoscopic technique with heel spur resection for the treatment of chronic plantar fasciitis will improve the functional results of the foot.
Methods: Patients diagnosed with chronic plantar fasciitis will undergo surgical treatment. An inspection is planned before and after 3, 6, 12, 24 and 60 months. During the check-up, the patient will undergo an X-ray examination, medical and physiotherapeutic assessment.
Study plan:
Participation in the research involves arriving at the Rehasport Clinic in Poznań on the dates set by the Chief Investigator (3, 6, 12, 24 and 60 months after the surgical treatment). During the visit, members of the research team ask participants to complete a set of questionnaires, perform a medical examination with a physiotherapeutic assessment described in detail below, and an X-ray examination. The entire examination will last approximately 3 hours.
- During all visits to Rehasport Clinic, the participant will be asked to complete the surveys ACFAS ankle and foot assessment scale.
During the same visits, research team members perform the following tests and examinations:
- medical examination - aimed at assessing current ailments and range of motion,
- X-ray examination of the foot.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- symptoms of chronic plantar fasciitis that have persisted for at least 6 months. despite previous conservative treatment, including corticosteroid injections, autologous PRP injections, physiotherapy, use of orthoses and NSAIDs,
- age ≥ 18 years,
- written consent to participate in the study
Exclusion Criteria:
- previous foot surgery,
- advanced diabetes impeding healing,
- significant obesity,
- contraindications to anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
Patients underwent endoscopic debridement coupled with heel spur resection.
This method emphasizes the removal of pathologically altered tissue while preserving the plantar aponeurosis, with the aim of minimizing procedural morbidity and enhancing recovery outcomes.
It specifically targets the crucial roles of the plantar fascia in supporting the foot arch and facilitating foot propulsion.
All had experienced persistent plantar fasciitis symptoms for at least six months despite conservative treatment.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
American Orthopedic Foot and Ankle Society (AOFAS) AnkleHindfoot Scale
Time Frame: 3 months - 60 months after the treatment
|
This comprehensive scale evaluates various aspects of foot health, including pain levels, functionality, and alignment, and is widely recognized for its reliability in orthopedic studies
|
3 months - 60 months after the treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tomasz Piontek, MD PhD, tomasz.piontek@rehasport.pl
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSC_TPION_2024_V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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