- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880318
Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
March 17, 2019 updated by: Ahmed Bahy Abdelaziz Ahmed, Assiut University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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".
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: spasmodic flat foot
extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot
|
extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assess the foot deformity
Time Frame: Baseline
|
assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
|
Baseline
|
assess the pain: Visual Analog Score
Time Frame: Baseline
|
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
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 1, 2019
Primary Completion (ANTICIPATED)
March 1, 2020
Study Completion (ANTICIPATED)
April 1, 2020
Study Registration Dates
First Submitted
December 30, 2018
First Submitted That Met QC Criteria
March 17, 2019
First Posted (ACTUAL)
March 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 17, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- spasmodic flat foot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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