Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
Primary Purpose
Flat Foot; Rigid, Flat Foot; Spastic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Joint Preserving Surgery in spasmodic flat foot
Sponsored by
About this trial
This is an interventional treatment trial for Flat Foot; Rigid
Eligibility Criteria
Inclusion Criteria:
- Painful, incorrectable pes Plano valgus after failure of conservative treatment
- Age: patients with skeletally mature foot as proved by x-ray
Exclusion Criteria:
- coalition bar
- Ankle subtalar joint arthritis.
- Previous foot fractures.
- Severe trophic skin disorders
- Standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
spasmodic flat foot
Arm Description
extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot
Outcomes
Primary Outcome Measures
assess the foot deformity
assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
assess the pain: Visual Analog Score
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. This tool was first used in psychology by Freyd in 1923
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03880318
Brief Title
Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
Official Title
Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
April 2020 (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
5. Study Description
Brief Summary
the investigators want to obtain a functional and radiological outcome of peroneus brevis, tertius and extensor digitorum longus muscles lengthening together with calcaneal osteotomies in the treatment of the spasmodic flat- foot.
Detailed Description
One of the most common foot complaints is the "flatfoot" deformity. Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. The rigid flatfoot deformity is an uncommon diagnosis (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment". Multiple causes of rigid flatfeet have been identified such as rheumatoid arthritis, tarsal coalitions (being the most common cause) that are excluded from that research. Triple arthrodesis is used for treatment of rigid flat foot but the patient satisfaction is not good as there is some stiffness in the foot .but here the investigators want to know what is the effect of extensor digitorum longus, peroneus brevis and tertius lengthening together with osteotomies in alignment of spasmodic flat- foot. In patient with rigid flat- foot or spasmodic flat- foot will often have the hind-foot alignment to the outside. Alignment of the heel influences how weight-bearing stress is applied to the foot, ankle, knee and hip. So, these patients may benefit from the calcaneal osteotomies and extensor digitorum longus, peroneus brevis and tertius lengthening to improve that alignment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Foot; Rigid, Flat Foot; Spastic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
spasmodic flat foot
Arm Type
Other
Arm Description
extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot
Intervention Type
Procedure
Intervention Name(s)
Joint Preserving Surgery in spasmodic flat foot
Intervention Description
extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies
Primary Outcome Measure Information:
Title
assess the foot deformity
Description
assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
Time Frame
Baseline
Title
assess the pain: Visual Analog Score
Description
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. This tool was first used in psychology by Freyd in 1923
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Painful, incorrectable pes Plano valgus after failure of conservative treatment
Age: patients with skeletally mature foot as proved by x-ray
Exclusion Criteria:
coalition bar
Ankle subtalar joint arthritis.
Previous foot fractures.
Severe trophic skin disorders
Standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".
12. IPD Sharing Statement
Learn more about this trial
Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
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