search
Back to results

Calcaneal Osteotomy for Intractable Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
calcaneal osteotomy for intractable plantar fasciitis
plantar fascia open release
plantar fascia endoscopic release
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring intractable plantar fasciitis, heel spur, anteromedial heel pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    plantar fascia release

    Plantar fascia endoscopic release

    Clacaneal osteotomy

    Arm Description

    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.

    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.

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    January 30, 2023
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05576376
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fascitis
    Keywords
    intractable plantar fasciitis, heel spur, anteromedial heel pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    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)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    plantar fascia release
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Plantar fascia endoscopic release
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Clacaneal osteotomy
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    calcaneal osteotomy for intractable plantar fasciitis
    Intervention Description
    plantar displacement calcaneal osteotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    plantar fascia open release
    Intervention Description
    open partial release with or without baxter's nerve decompression
    Intervention Type
    Procedure
    Intervention Name(s)
    plantar fascia endoscopic release
    Intervention Description
    endoscopic partial plantar fascia release
    Primary Outcome Measure Information:
    Title
    the change in the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale (AOFAS score)
    Description
    score of 100 points.higher score means better function with less pain and good alignment
    Time Frame
    6 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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: 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. age groups below 18 years old and above 65 years old. Plantar fasciitis cases with pes planus.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Calcaneal Osteotomy for Intractable Plantar Fasciitis

    We'll reach out to this number within 24 hrs