Fasciitis, PlantarNCT06535724
Endoscopic Debridement of Chronic Plantar Fasciitis
A study testing Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection in people with Fasciitis, Plantar and Fasciitis, Plantar, Chronic, run by Rehasport Clinic.
Trial summary
The aim of the study was to prospectively evaluate the results of endoscopic treatment of chronic plantar fasciitis with resection of the heel spur. Treatment was assessed based on the results of clinical examinations and functional assessment as well as X-ray examination. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fasciitis, Plantar, Fasciitis, Plantar, Chronic, Heel Spur
- What is being tested?
- Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous foot surgery,
- advanced diabetes impeding healing,
- significant obesity,
- contraindications to anesthesia
About this study
Official title: Endoscopic Debridement of Chronic Plantar Fasciitis With Heel Spur Resection: a Novel Technique With Promising Outcomes - a Prospective Cohort Study
The aim of the study was to prospectively evaluate the results of endoscopic treatment of chronic plantar fasciitis with resection of the heel spur. Treatment was assessed based on the results of clinical examinations and functional assessment as well as X-ray examination.
Read the 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.
- Conditions
- Fasciitis, Plantar, Fasciitis, Plantar, Chronic, Heel Spur
- Being tested
- Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection
- Medical subject headings
- Fasciitis, Plantar, Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic plantar fasciitis endoscopic debridement coupled with heel spur resectionProcedure or surgery
- Preoperative Preparation: popliteal nerve block, patient positioning supine with the operated limb fully externally rotated, spinal anesthesia, tourniquet application.
- Surgical Procedure:
- Initial Marking from the heel bone arch to the calcaneal bone to locate the entry point.
- First Incision and Portal Creation: an initial incision at the palpated site using a size 11 blade; blunt dissection to reveal the plantar fascia; arthroscope entry.
- Secondary Entry: 3 cm distally from the initial incision; positioning of the arthroscope; additional blunt dissection and obturator insertion.
- Operative Technique: continuous irrigation with sterile saline; 3.5-mm shaver introduced through the distal portal; meticulous debridement of inflamed and pathological tissue; removal of calcaneal spurs; thinning of the plantar fascia
- Postoperative Care • Careful monitoring and guided rehabilitation to support optimal healing and recovery.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Procedure: Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society (AOFAS) AnkleHindfoot Scale
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
Measured: 3 months - 60 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehasport Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Piontek, MD PhD, Principal investigator, tomasz.piontek@rehasport.pl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535724
- Sponsor's protocol ID
- RSC_TPION_2024_V1
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Debridement of Chronic Plantar Fasciitis With Heel Spur Resection: a Novel Technique With Promising Outcomes - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06535724
- Acronym / sponsor ID
- RSC_TPION_2024_V1
- Conditions
- Fasciitis, Plantar, Fasciitis, Plantar, Chronic, Heel Spur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rehasport ClinicUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Aug 2024 (actual)
- 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.
The aim of the study was to prospectively evaluate the results of endoscopic treatment of chronic plantar fasciitis with resection of the heel spur. Treatment was assessed based on the results of clinical examinations and functional assessment as well as X-ray examination.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Chronic plantar fasciitis endoscopic debridement coupled with heel spur resectionPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- previous foot surgery,
- advanced diabetes impeding healing,
- significant obesity,
- contraindications to anesthesia
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 |
|---|---|---|
| Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection1. Preoperative Preparation: popliteal nerve block, patient positioning supine with the operated limb fully externally rotated, spinal anesthesia, tourniquet application. 2. Surgical Procedure: * Initial Marking from the heel bone arch to the calcaneal bone to locate the entry point. * First Incision and Portal Creation: an initial incision at the palpated site using a size 11 blade; blunt dissection to reveal the plantar fascia; arthroscope entry. * Secondary Entry: 3 cm distally from the initial incision; positioning of the arthroscope; additional blunt dissection and obturator insertion. * Operative Technique: continuous irrigation with sterile saline; 3.5-mm shaver introduced through the distal portal; meticulous debridement of inflamed and pathological tissue; removal of calcaneal spurs; thinning of the plantar fascia 3. Postoperative Care • Careful monitoring and guided rehabilitation to support optimal healing and recovery. | Procedure or surgery | Study group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Tomasz Piontek, MD PhD principal investigator
tomasz.piontek@rehasport.pl
Questions about this trial
What is this clinical trial studying?
A study testing Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection in people with Fasciitis, Plantar and Fasciitis, Plantar, Chronic, run by Rehasport Clinic.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
American Orthopedic Foot and Ankle Society (AOFAS) AnkleHindfoot Scale (time frame: 3 months - 60 months after the treatment). 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 2 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.