NCT03880318

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

December 30, 2018

Last Update Submit

March 17, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • assess the foot deformity

    assess foot deformity : full correction (valgus\<10 degree), partial correction(valgus\<15 degree),valgus \>15 degree)

    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

    Baseline

Study Arms (1)

spasmodic flat foot

OTHER

extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot

Procedure: Joint Preserving Surgery in spasmodic flat foot

Interventions

extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies

spasmodic flat foot

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Painful, incorrectable pes Plano valgus after failure of conservative treatment
  • Age: patients with skeletally mature foot as proved by x-ray

You may not qualify if:

  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FlatfootMuscle RigidityMuscle Spasticity

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMuscular DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at Assiut University hospitals

Study Record Dates

First Submitted

December 30, 2018

First Posted

March 19, 2019

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

March 19, 2019

Record last verified: 2019-03