Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy

NCT ID: NCT05342207

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-04-30

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

Conditions

in Cases of Chronic Resistant Plantar Fasciopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cases

Group Type: EXPERIMENTAL

Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Saeed Hamdy

Orthopedic surgery resident at sohag university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

Mohammed S Hamdy, resident

Role: CONTACT

mohamed011155@med.sohag.edu.eg

01025145663

Hassan H Noaman, professor

Role: CONTACT

Facility Contacts

Osama R ElSherif, professor

Role: primary

References

Cottom JM, Maker JM, Richardson P, Baker JS. Endoscopic Debridement for Treatment of Chronic Plantar Fasciitis: An Innovative Technique and Prospective Study of 46 Consecutive Patients. J Foot Ankle Surg. 2016 Jul-Aug;55(4):748-52. doi: 10.1053/j.jfas.2016.02.005. Epub 2016 Apr 5.

Reference Type: BACKGROUND

PMID: 27066869 (View on PubMed)

Lui TH. Endoscopic Decompression of the First Branch of the Lateral Plantar Nerve and Release of the Plantar Aponeurosis for Chronic Heel Pain. Arthrosc Tech. 2016 Jun 6;5(3):e589-94. doi: 10.1016/j.eats.2016.02.018. eCollection 2016 Jun.

Reference Type: BACKGROUND

PMID: 27656382 (View on PubMed)

Oliva F, Piccirilli E, Berardi AC, Frizziero A, Tarantino U, Maffulli N. Hormones and tendinopathies: the current evidence. Br Med Bull. 2016 Mar;117(1):39-58. doi: 10.1093/bmb/ldv054. Epub 2016 Jan 19.

Reference Type: BACKGROUND

PMID: 26790696 (View on PubMed)

Sabir N, Demirlenk S, Yagci B, Karabulut N, Cubukcu S. Clinical utility of sonography in diagnosing plantar fasciitis. J Ultrasound Med. 2005 Aug;24(8):1041-8. doi: 10.7863/jum.2005.24.8.1041.

Reference Type: BACKGROUND

PMID: 16040817 (View on PubMed)

Other Identifiers

Soh-Med-22-03-06

Identifier Type: -

Identifier Source: org_study_id