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Calcaneal Osteotomy for Intractable Plantar Fasciitis

Management of Intractable Plantar Fasciitis by Plantar Fascia Release Compared With Plantar Displacement Calcaneal Osteotomy: Randomized Control Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05576376
Enrollment
60
Registered
2022-10-12
Start date
2023-03-31
Completion date
2025-10-31
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fascitis

Keywords

intractable plantar fasciitis, heel spur, anteromedial heel pain

Brief 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.

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?

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Each patient will be randomly assigned to his group using quick Calcs methodfor randomization (https://www.graphpad.com/quickcalcs/randomize1/) either group A (plantar fascia open release) or group B (Plantar fascia endoscopic release) or group C( calcaneal osteotomy)

Intervention model description

We aim to achieve 35% percentage difference between both techniques with 80% power at a 5% (two-sided) significance level with alpha error 5%. For this power, a sample size of 54 patients will be required with assuming 10% drop out. So, a total of 60 patients will be enrolled (30 patients in each arm).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 steroid injection

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.

Design outcomes

Primary

MeasureTime frameDescription
the change in the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale (AOFAS score)6 months after surgeryscore of 100 points.higher score means better function with less pain and good alignment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026