Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative TreatmentNCT06562062
Radiological Outcomes of Modified Extra-articular LCL
An observational study of Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment, run by Assiut University at 1 site in Egypt.
Trial summary
To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment
- What is being tested?
- Extra-articular Lateral Column Lengthening Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Aug 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult flexible acquired flatfoot deformity which doesn\'t include genetic or spasmodic flatfoot deformity in children
Who may be able to join
- 1) Age : adult ( age above 16 years old and below 65 years old
- 2) symptomatic flexible flat foot after failure of Conservative treatment
Who cannot join
- 1- Age: (\<16,\>65) years old 2 -Previous foot surgery 3- autoimmune disease
- 4 Uncontrolled blood sugar 5- Osteoprotic patient 6- Infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine assiut university
Asyut, Assiuu
Amr Abo Alfadle, Lecturer, +201007788699, Amr.a.mohamed@aun.edu.eg
About this study
Official title: Radiological Outcomes of Modified Extra-articular Lateral Column Lengthening Procedure for Correction of Adult Acquired Flexible Flatfoot Deformity
To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity
Read the detailed description
Measurement of
- Calcencal pitch : This angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface(10), normal ranges of between 10-25° and 20-30 have Been proposed(11)
- Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , typically', Meary's angle is 0°, with abnormal values considered angle >4° convex upward: pes cavus , angle <-4 convex downward: pes planus, It can be used to classify the severity of deformity
- lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis , The lateral talocalcaneal angle should normally measure between 25 and 40°, >40° diagnoses flatfoot deformity(12)
- Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface) ,Interpreting the talonavicular coverage angle (13)Normal: <7,Adult Acquired flatfoot disease: >7°
- Being tested
- Extra-articular Lateral Column Lengthening Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-articular Lateral Column Lengthening ProcedureProcedure or surgery
Lateral column lengthening (LCL), originally described by Evans, is an established procedure to correct stage II adult acquired flatfoot deformity (AAFD). However, the relative position between the facets is violated, and other problems may include nonunion, malunion, and calcaneocuboid (CC) joint subluxation. Herein, we report a modified extra-articular technique of LCL with hockey-stick osteotomy, which preserves the subtalar joint as a whole, increases bony apposition to enhance healing ability, and preserves the insertion of the calcaneofibular ligament to stabilize the posterior fragment to promote adduction of the forefoot
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological outcome & by standard erect plain x ray after 3 months
Measurement of
- Calcencal pitch : this angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface , correction angle needed ≈ 15-25°.
- Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , correction angle needed ≈ 0-1°.
- lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis correction angle ≈ 25 and 40° .
- Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface
Measured: 3 months after the surgery
Secondary outcomes (1)
clinical outcome by American orthopedic foot and ankle score (hindfoot
Measured: 6 months after the surgery when the patient restore his life activities maximally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start16 Aug 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative TreatmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Eldeen Kamal Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562062
- Sponsor's protocol ID
- Extra-articular LCL of AAFFD
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Aug 2024
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Outcomes of Modified Extra-articular Lateral Column Lengthening Procedure for Correction of Adult Acquired Flexible Flatfoot Deformity
- ClinicalTrials.gov ID
- NCT06562062
- Acronym / sponsor ID
- Extra-articular LCL of AAFFD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Aug 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 20 Aug 2024 (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.
To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity
Detailed description
Measurement of
- Calcencal pitch : This angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface(10), normal ranges of between 10-25° and 20-30 have Been proposed(11)
- Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , typically', Meary's angle is 0°, with abnormal values considered angle >4° convex upward: pes cavus , angle <-4 convex downward: pes planus, It can be used to classify the severity of deformity
- lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis , The lateral talocalcaneal angle should normally measure between 25 and 40°, >40° diagnoses flatfoot deformity(12)
- Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface) ,Interpreting the talonavicular coverage angle (13)Normal: <7,Adult Acquired flatfoot disease: >7°
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult flexible acquired flatfoot deformity which doesn\&#39;t include genetic or spasmodic flatfoot deformity in children
Key inclusion criteria (2 listed)
- 1) Age : adult ( age above 16 years old and below 65 years old
- 2) symptomatic flexible flat foot after failure of Conservative treatment
Key exclusion criteria (2 listed)
- 1- Age: (\&lt;16,\&gt;65) years old 2 -Previous foot surgery 3- autoimmune disease
- 4 Uncontrolled blood sugar 5- Osteoprotic patient 6- Infection
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 |
|---|---|---|
| Extra-articular Lateral Column Lengthening ProcedureLateral column lengthening (LCL), originally described by Evans, is an established procedure to correct stage II adult acquired flatfoot deformity (AAFD). However, the relative position between the facets is violated, and other problems may include nonunion, malunion, and calcaneocuboid (CC) joint subluxation. Herein, we report a modified extra-articular technique of LCL with hockey-stick osteotomy, which preserves the subtalar joint as a whole, increases bony apposition to enhance healing ability, and preserves the insertion of the calcaneofibular ligament to stabilize the posterior fragment to promote adduction of the forefoot | Procedure or surgery | – |
Primary outcome
Radiological outcome & by standard erect plain x ray after 3 months
Time frame: 3 months after the surgery
Measurement of 1. Calcencal pitch : this angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface , correction angle needed ≈ 15-25°. 2. Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , correction angle needed ≈ 0-1°. 3. lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis correction angle ≈ 25 and 40° . 4. Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface
1 secondary outcome
clinical outcome by American orthopedic foot and ankle score (hindfoot
Time frame: 6 months after the surgery when the patient restore his life activities maximally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment, run by Assiut University at 1 site in Egypt.
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 2 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: looking for participants now, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hosam Eldeen Kamal Mohamed, Resident (+201015106584, Hossam.15235597@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological outcome & by standard erect plain x ray after 3 months (time frame: 3 months after the surgery). 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 20 Aug 2024.