- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436923
Calcaneal Osteotomy for Recalcitrant Planter Fasciosis
Evaluation of Results of Calcaneal Osteotomy in Adult Patient With Recalcitrant Planter Fasciosis: Short Term Results
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Plantar fasciosis is a leading cause of heel pain in adults and represents a degenerative rather than inflammatory condition of the plantar fascia. Most cases resolve with conservative measures; however, up to 10-15% remain symptomatic and may require surgical intervention.
Plantar fascia release-either open or endoscopic-remains a standard surgical option for recalcitrant cases. However, this procedure may compromise foot biomechanics. Recent biomechanical and clinical studies have demonstrated that partial or complete release reduces longitudinal arch height and increases midfoot strain, particularly when more than 50% of the fascia is divided. Such alterations in load distribution can result in lateral column overload, metatarsalgia, and sinus tarsi pain. Endoscopic release has also been associated with medial arch reduction and the development of lateral column symptoms within months postoperatively, further highlighting these risks. Additionally, comparative studies report wound complications, nerve irritation, and recurrence of heel pain in a notable subset of patients undergoing plantar fasciotomy. Up to 50% of patients may experience persistent or recurrent pain following the procedure.
Entrapment of the first branch of the lateral plantar nerve (Baxter's nerve) is another under-recognized cause of chronic heel pain, often coexisting with or mimicking plantar fasciosis. Decompression of Baxter's nerve, either alone or combined with limited plantar fascia release, has been shown to improve outcomes in resistant cases.
Given these limitations, calcaneal osteotomy has emerged as alternative surgical strategies. By altering the mechanical axis of the calcaneus and inducing localized bone remodeling, these techniques aim to unload the plantar fascia insertion without compromising arch stability. Early reports suggest that calcaneal osteotomy, particularly when combined with Baxter's nerve release, may offer superior pain relief and functional recovery in recalcitrant plantar fasciosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: George Botros Mosa, Master
- Phone Number: +201012762194
- Email: george.17289633@med.aun.edu.eg
Study Contact Backup
- Name: Ahmed Ekram Osman, PhD
- Phone Number: +201012756356
- Email: ahmed.osman@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All adult patients with age range from 18 to 65 years with unilateral or bilateral planter fasciosis after clinical and radiological diagnosis confirmation, who failed conservative treatment for at least 6 months or recurrent cases.
- MRI & US proof of planter fasciosis showing thickness of planter fascia >4mm
Exclusion Criteria:
- All other causes of heel pain including polyneuropathy, planter fascia rupture, seronegative arthropathies, rheumatoid arthritis in bilateral cases, abscess or neoplasm affecting the soft tissue, and bone occult fracture or infection.
- Age groups below 18 years old and above 65 years old.
- Plantar fasciosis cases having pes planus with diffuse foot pain not only localized to the planter fascia origin (the medial tubercle of the calcaneus - a bony prominence on the inferomedial aspect of the calcaneus).
- Diabetic patients
- Primary tarsal tunnel syndrome (not presented secondary to a deformity or another cause)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Calcaneal osteotomy
Calcaneal osteotomy skin incision will be oblique and directed from the infero-posterior edge of the lateral malleolus to the inferior edge of the calcaneal body, and you should be careful not to cause injury to the sural nerve.
Osteotomy of the exposed lateral wall will be performed from 1 cm anterior to the calcaneal attachment of the plantar fascia to 1 cm anterior to 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.
Patients with a pronated foot before surgery will have an additional approximately 5 mm medial displacement of the proximal fragment simultaneously to correct malalignment.
Fixation after the osteotomy will be performed under an image intensifier using one or two cannulated cancellous screws 7.3 mm in diameter, which will be inserted from the infero-medial of the calcaneal tuberosity to the distal fragment.
|
planter displacement calcaneal osteotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AOFAS score
Time Frame: 6 months after surgery
|
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
|
6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS
Time Frame: 12 months
|
Pain assessment measured pre & post-operative by VAS (Visual Analog Scale) at 12 months
|
12 months
|
|
Foot pressure
Time Frame: 12 months
|
Foot pressure measurement pre & post-operative
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
- Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Rodriguez-Sanz J, Roche-Seruendo LE, Lopez-de-Celis C, Canet-Vintro M, Ordoyo-Martin J, Fernandez-Gibello A, Labata-Lezaun N, Perez-Bellmunt A. Effects of Plantar Fascia Release and the Use of Foot Orthoses Affect Biomechanics of the Medial Longitudinal Arch of the Foot: A Cadaveric Study. Am J Phys Med Rehabil. 2024 Jul 1;103(7):595-602. doi: 10.1097/PHM.0000000000002414. Epub 2024 Jan 12.
- Liew SK, Saw A, Chua YP. Foot Arch Changes after Endoscopic Plantar Fascia Release for Recalcitrant Plantar Fasciitis. Malays Orthop J. 2022 Jul;16(2):78-86. doi: 10.5704/MOJ.2207.010.
- Baxter DE, Thigpen CM. Heel pain--operative results. Foot Ankle. 1984 Jul-Aug;5(1):16-25. doi: 10.1177/107110078400500103.
- Yanbin X, Haikun C, Xiaofeng J, Wanshan Y, Shuangping L. Treatment of Chronic Plantar Fasciitis With Percutaneous Latticed Plantar Fasciotomy. J Foot Ankle Surg. 2015 Sep-Oct;54(5):856-9. doi: 10.1053/j.jfas.2015.02.008. Epub 2015 Jun 6.
- Kalen V, Brecher A. Relationship between adolescent bunions and flatfeet. Foot Ankle. 1988 Jun;8(6):331-6. doi: 10.1177/107110078800800609.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- osteotomy in planter fasciosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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