Flat Foot; RigidNCT03880318
Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
A study testing Joint Preserving Surgery in spasmodic flat foot in people with Flat Foot; Rigid and Flat Foot; Spastic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Flat Foot; Rigid, Flat Foot; Spastic
- What is being tested?
- Joint Preserving Surgery in spasmodic flat foot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Painful, incorrectable pes Plano valgus after failure of conservative treatment
- Age: patients with skeletally mature foot as proved by x-ray
Who cannot join
- 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".
About this study
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.
Read the 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.
- Conditions
- Flat Foot; Rigid, Flat Foot; Spastic
- Being tested
- Joint Preserving Surgery in spasmodic flat foot
- Medical subject headings
- Flatfoot, Muscle Rigidity, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Preserving Surgery in spasmodic flat footProcedure or surgery
extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies
| Study group | Role | What they receive |
|---|---|---|
| spasmodic flat foot | Other | extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot Receives: Procedure: Joint Preserving Surgery in spasmodic flat foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the foot deformity
assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Foot; RigidStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Bahy Abdelaziz Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880318
- Sponsor's protocol ID
- spasmodic flat foot
- Status last verified
- Mar 2019
- First submitted
- 30 Dec 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
- ClinicalTrials.gov ID
- NCT03880318
- Acronym / sponsor ID
- spasmodic flat foot
- Conditions
- Flat Foot; Rigid, Flat Foot; Spastic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spasmodic flat foot | Other | Procedure: Joint Preserving Surgery in spasmodic flat footextensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Painful, incorrectable pes Plano valgus after failure of conservative treatment
- Age: patients with skeletally mature foot as proved by x-ray
Key exclusion criteria (5 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint Preserving Surgery in spasmodic flat footextensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies | Procedure or surgery | spasmodic flat foot |
Primary outcome
assess the foot deformity
Time frame: Baseline
assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Preserving Surgery in spasmodic flat foot in people with Flat Foot; Rigid and Flat Foot; Spastic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the foot deformity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.