NCT04911686

Brief Summary

The aim of our study is to produce gradual correction of FKFD in younger children.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

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

May 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

May 28, 2021

Last Update Submit

May 28, 2021

Conditions

Flexion Deformity of Knee

Outcome Measures

Primary Outcomes (1)

  • Correction of fixed knee flexion deformities in children using cast and rod distraction

    Amount of correction of the flexion deformity measured in degrees

    baseline

Secondary Outcomes (1)

  • Correction of fixed knee flexion deformities in children using cast and rod distraction

    baseline

Interventions

rod distractionDEVICE

Our study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.

Also known as: hemiephysiodesis

Eligibility Criteria

AgeUp to 4 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with FKFD Age \< 4 years.

You may qualify if:

  • Children with FKFD.
  • Age \< 4 years.
  • FKFD due to congenital, traumatic, neuromuscular, infections, metabolic disorders and skeletal dysplasias.

You may not qualify if:

  • \. Older children less than 4 years 2. Recent Post-burn contractures and cases with unsuitable skin conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Balci HI, Kocaoglu M, Eralp L, Bilen FE. Knee flexion contracture in haemophilia: treatment with circular external fixator. Haemophilia. 2014 Nov;20(6):879-83. doi: 10.1111/hae.12478. Epub 2014 Aug 21.

    PMID: 25143070BACKGROUND

  • Spiro AS, Stenger P, Hoffmann M, Vettorazzi E, Babin K, Lipovac S, Kolb JP, Novo de Oliveira A, Rueger JM, Stuecker R. Treatment of fixed knee flexion deformity by anterior distal femoral stapling. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2413-8. doi: 10.1007/s00167-012-1915-8. Epub 2012 Feb 4.

    PMID: 22307752BACKGROUND

Study Officials

  • Mohamed Khaled Hassan Ahmed, professor

    Analysis and interpretation of data

    STUDY DIRECTOR

Central Study Contacts

Alm Eldeen khalf sholkamy, master

CONTACT

01140876327alam.khalalf@yahoo.com

Nariman El-Sayed Mohammad, doctor

CONTACT

01222302343aboloyoun@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 3, 2021

Study Start

June 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

June 3, 2021

Record last verified: 2021-03