NCT06535724

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

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

January 1, 2013

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

11 years

First QC Date

July 23, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months - 60 months after the treatment

Study Arms (1)

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.

Procedure: Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection

Interventions

1. 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.

Study group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • previous foot surgery,
  • advanced diabetes impeding healing,
  • significant obesity,
  • contraindications to anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fasciitis, PlantarHeel Spur

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesExostosesHyperostosisBone Diseases

Study Officials

  • Tomasz Piontek, MD PhD

    tomasz.piontek@rehasport.pl

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 2, 2024

Study Start

January 1, 2013

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share