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Not yet recruitingNCT05576376Updated Jan 31, 2023

Calcaneal Osteotomy for Intractable Plantar Fasciitis

An interventional study of calcaneal osteotomy for intractable plantar fasciitis and plantar fascia open release in Plantar Fascitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is to clarify the efficacy of plantar displacement calcaneal osteotomy for intractable plantar fasciitis by decreasing the tension of the plantar fascia around the calcaneal attachment while keeping the plantar fascia intact and comparing it with the plantar fascia release in pain control, job return and foot arch preservation.

Read the detailed description

Plantar fasciitis (PF) is the most common cause of heel pain accounting for 15% of all foot symptoms requiring medical care and 1% of patient visits to orthopaedic surgeons in the United states.

The diagnosis is straight forward; the challenge is finding an effective and economic first line treatment. The annual costs of plantar fasciitis are $284 million, that does not include opportunity cost from lost work and wages, societal burden, and psychologic burden.

Histologic examination shows myxoid degeneration with fragmentation and degeneration of the plantar fascia and supports being a degenerative fasciitis without inflammation. Therefore, plantar fasciopathy is a more accurate descriptor.

Treatment is largely nonoperative, with 85% to 90% of patients experiencing resolution of symptoms within 6-12 months. Partial or complete plantar fasciotomy, either open or endoscopic is indicated only for intractable cases with failed conservative treatment.

Fascia release, being the main surgery, sometimes accompanied by complications, one of which is lateral column pain due to loss of the longitudinal arch height caused by the release of the plantar fascia with no consensus regarding the amount of the plantar fascia which should be released in order to relieve pain without causing lateral column pain.

To avoid this complication, we need to study the efficacy of calcaneal osteotomy for the surgical treatment of PF. Does the calcaneal osteotomy is an effective alternative surgical treatment option compared to the standard plantar fascia release in cases of resistant PF?

02

Conditions studied

  • Plantar Fascitis

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Keywords

  • intractable plantar fasciitis
  • heel spur
  • anteromedial heel pain
03

In context

Heel Spur

32 studies on the registry are indexed under Heel Spur; 10 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 25 interventional studies indexed under Heel Spur.

Browse Heel Spur studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All adult patients with age range from 18 to 65 years with unilateral or bilateral PF after clinical and radiological diagnosis confirmation, who had failed conservative treatment for at least 6 months or recurrent cases after injection

Exclusion criteria

Exclusion Criteria:

  1. All other causes of heel pain including seronegative arthropathies, rheumatoid arthritis in bilateral cases, abscess or neoplasm affecting the soft tissue, and bone occult fracture or infection.
  2. age groups below 18 years old and above 65 years old.
  3. Plantar fasciitis cases with pes planus.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    plantar fascia release

    plantar fascia open release Longitudinal incision at the medial heel, Exposure of the plantar fascia at its origin on the medial plantar calcaneus. Medial incision of the plantar fascia preserving the lateral portion.. Exposure of the abductor hallucis muscle. Incision of the superficial fascia of the muscle. Retraction of the muscle belly und incision of the deep portion of the fascia, decompression of the first calcaneal branch of the lateral plantar nerve (Baxter's nerve) in cases of its being compressed. Postoperative management: Two weeks partial weight bearing. Progressively weight bearing using a shoe with a stiff sole for another 4 weeks.

    Procedure: plantar fascia open release

  • Experimental
    Plantar fascia endoscopic release

    We will draw a line distally from the posterior aspect of the medial malleolus to the intersection of the medial origin of the plantar fascia at the calcaneal tuberosity. A skin incision will be made, and medial portal will be performed at this location. Blunt dissection will be performed to clear the subcutaneous tissue from the plantar fascia with caution to avoid lesion of the calcaneal nerve medial branch.

    Procedure: plantar fascia endoscopic release

  • Experimental
    Clacaneal osteotomy

    calcaneal osteotomy skin incision will be oblique and directed from the inferoposterior edge of the lateral malleolus to the inferior edge of the calcaneal body, and subperiosteal exposure of the lateral calcaneal wall will be performed. Osteotomy will be performed from 1 cm anterior of the calcaneal attachment of the plantar fascia to 1 cm anterior of the calcaneal attachment of the Achilles tendon. After the osteotomy, approximately 5 mm plantar displacement of the proximal fragment, which include attachment of the plantar fascia, will be performed. Fixation after the osteotomy will be performed under an image intensifier using one cannulated cancellous screws 4.5 mm in diameter, which will be inserted from the infero-medial of the calcaneal tuberosity to the distal fragment

    Procedure: calcaneal osteotomy for intractable plantar fasciitis

Interventions

  • Procedurecalcaneal osteotomy for intractable plantar fasciitis

    plantar displacement calcaneal osteotomy

  • Procedureplantar fascia open release

    open partial release with or without baxter's nerve decompression

  • Procedureplantar fascia endoscopic release

    endoscopic partial plantar fascia release

06

What researchers measure

Primary outcomes

  1. the change in the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale (AOFAS score)

    score of 100 points.higher score means better function with less pain and good alignment

    Time frame: 6 months after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05576376
Lead sponsor
Assiut University
Responsible party
El-Taher Alaa Eldin Ahmed Eid (principle investigator, Assiut University) — Principal investigator
First posted
Oct 12, 2022
Start date
Mar 2023 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jan 31, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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