Clinical trial NCT05576376: Calcaneal Osteotomy for Intractable Plantar Fasciitis
Official title: Management of Intractable Plantar Fasciitis by Plantar Fascia Release Compared With Plantar Displacement Calcaneal Osteotomy: Randomized Control Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Keywords: intractable plantar fasciitis
heel spur
anteromedial heel pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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?

Eligibility criteria: 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.

Primary outcomes:
measure: the change in the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale (AOFAS score)
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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