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RecruitingNCT06562062Updated Aug 20, 2024

Radiological Outcomes of Modified Extra-articular LCL

An observational study in Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1
Ages
16 Years to 65 Years
Sex
All
01

Study summary

To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity

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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(10), normal ranges of between 10-25° and 20-30 have Been proposed(11)
  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) , 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
  3. 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)
  4. 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°
02

Conditions studied

  • Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment

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03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 1 is below the median of 47 across 48 observational studies indexed under Flatfoot.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult flexible acquired flatfoot deformity which doesn\&#39;t include genetic or spasmodic flatfoot deformity in children

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Age : adult ( age above 16 years old and below 65 years old
  1. symptomatic flexible flat foot after failure of Conservative treatment

Exclusion criteria

Exclusion Criteria:

  • 1- Age: (\&lt;16,\&gt;65) years old 2 -Previous foot surgery 3- disease
  • 4 Uncontrolled blood sugar 5- Osteoprotic patient 6- Infection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1 participant (estimated)
Patient registry
No

Interventions

  • ProcedureExtra-articular Lateral Column Lengthening Procedure

    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

06

What researchers measure

Primary outcomes

  1. Radiological outcome & by standard erect plain x ray after 3 months

    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

    Time frame: 3 months after the surgery

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06562062
Lead sponsor
Assiut University
Responsible party
Hosam Eldeen Kamal Mohamed (Hosam Eldeen Kamal Mohamed, Assiut University) — Principal investigator
First posted
Aug 20, 2024
Start date
Aug 16, 2024 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Aug 20, 2024

Study contacts

Hosam Eldeen Kamal Mohamed, Resident
Contact
Hossam.15235597@med.aun.edu.eg
+201015106584

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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