Correction of Fixed Knee Flexion Deformity in Children Distraction by Cast Wedge and Rod Lengthening

May 28, 2021 updated by: Alm-Eldeen khalf sholkamy, Assiut University
The aim of our study is to produce gradual correction of FKFD in younger children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Management of pediatric fixed knee flexion deformities (FKFD) has always been a challenge for orthopedic surgeons. They occur due to a variety of causes, including cerebral palsy, arthrogryposis, spina bifida, trauma, and many others. The deleterious effects of FKFD include instability of gait and balance, exhaustion of extensor mechanism, and anterior knee pain, which together produce marked limitation of the activities of daily living in affected children .

Many options have been proposed for the correction of FKFD, with each having its pros and cons. Hamstring release and posterior capsulotomy are frequently used. However, extensive soft tissue release may be needed to treat severe deformities with the risk of neurovascular compromise and genu recurvatum. Supracondylar extension osteotomy with patellar tendon advancement requires postoperative non-weight bearing for at least three weeks and is associated with risk of neurovascular damage and coronal plane deformities and it is mostly used in older children and adolescent . Gradual distraction by ring fixators may be complicated by pin tract problems, fractures, and recurrence .

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with FKFD Age < 4 years.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correction of fixed knee flexion deformities in children using cast and rod distraction
Time Frame: baseline
Amount of correction of the flexion deformity measured in degrees
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correction of fixed knee flexion deformities in children using cast and rod distraction
Time Frame: baseline
Rate of correction Monitor patients and report on complication like severe knee joint pain or posterior translation of tibia within the study period, pressure ulcers caused by cast indentation.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohamed Khaled Hassan Ahmed, professor, Analysis and interpretation of data

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Knee flexion deformities

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Flexion Deformity of Knee

Clinical Trials on rod distraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe