Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05342207
Collaborator
(none)
30
1
1
12
2.5

Study Details

Study Description

Brief Summary

The plantar fascia is a thick tissue band that connects the heel bone (the medial tubercle of the under surface of the calcaneus) to the metatarsophalangeal joints, forming the medial arch of the foot, which supports the foot during walking. Irritation and scarring of the plantar fascia is one of the most common causes of heel pain .

Plantar fasciopathy accounts for 11% to 15% of all foot disorders in both athletes and sedentary patients .

Although commonly referred to using incorrect nomenclature as plantar fasciitis ,it is degenerative process (i.e. fasciopathy).The etiology of plantar fasciopathy is not clear. It can result from irritation due to overstrain of the fascia, which induces mucoid degeneration The pathologic findings include degenerative tissue changes without inflammatory mediators .

The diagnosis of plantar fasciopathy is determined by the medical history and physical examination findings. Typically, patients present with heel pain during weight bearing , especially in the early morning and with the first steps after a period of inactivity .

Patients will usually have tenderness around the site of the plantar aponeurosis . The pain can be reproduced by stretching the diseased plantar aponeurosis by passive hyperextension of the metatarsophalangeal joints .

Endoscopic plantar fasciotomy is a relatively new procedure, involves an endoscopic approach to the heel, allowing a plantar aponeurosis release to be performed with delicate instruments, minimal dissection, and immediate weight bearing

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: cases

Procedure: Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy
A medial portal will be developed 1cm away from the plantar skin along a vertical line passing through the posterior border of the medial malleolus with the foot in neutral position. A 5 mm cannula will be then introduced through the lateral portal over the trocar. Irrigation fluid will be then connected. A 30-degree 4.0 mm endoscope will be inserted inside the cannula. A 4.5 motorized incisor blade will be then used to debride the subcutaneous tissue until full visualization of the shiny fibers of the plantar fascia will be possible. A needle was inserted vertically through the heel skin to act as a land mark for the middle of the plantar fascia. A scalpel blade will then introduced through the medial portal to divide the full thickness of the medial half of the plantar fascia into two leaflets under direct visualization . The posterior leaflet will be then totally debrided using a motorized incisor blade . The tunnel will then be irrigated and stitches will be done.

Outcome Measures

Primary Outcome Measures

  1. American Orthopedic Foot and Ankle-Hind foot Scale [6 months following operation]

    Pain Function Alignment assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adults more than 18 years old presented by a single site heel pain with local pressure at the origin of plantar fascia on the medial Calcaneal tuberosity for one year, with failure of at least two lines of conservative treatment including:

Non-steroidal anti-inflammatory drugs (NSAIDs), Corticosteroid injections, physical therapy, exercise program (Achilles tendon and plantar fascia stretching exercises) and orthotic devices (heel cup, molded shoe insert or night splint) for at least 3 months.

Exclusion Criteria:
  • Patients younger than 18 years.

  • Patients who had a local infection or a metabolic disorder especially diabetes, generalized polyarthritis, sero-negative arthropathy, , tarsal tunnel syndrome.

  • Patients with congenital anomalies e.g pesplanus, pescavus, limb length discrepancy, in-toeing, neuro-muscular disorders.

  • Patients with an ipsilateral or contralateral vascular or neurological abnormalities, or malignancies.

  • Recent trauma or foot and ankle deformity or fractures.

  • Active anticoagulation therapy or bleeding disorders

  • Patients who received a corticosteroid injection within the previous four weeks.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Saeed Hamdy, Orthopedic surgery resident at sohag university, Sohag University
ClinicalTrials.gov Identifier:
NCT05342207
Other Study ID Numbers:
  • Soh-Med-22-03-06
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 22, 2022