Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting.

The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. The horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis.

The goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis

Study Overview

• Status: Not yet recruiting
• Conditions: Deformities Around the Knee in Pedietrics
• Intervention / Treatment: Procedure: correction of deformities around the knee with external fixator

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed m eldeeb, resident doctor; Phone Number: 01062851905; Email: mohamed011166@med.sohag.edu.eg
• Study Contact Backup: Name: Ahmed i addosooki, professor; Phone Number: 01011110232

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Genu valgus having tibio-femoral angle more than 15 degrees.
• Genu varus having metaphyseal-diaphyseal angle of more than 11 degrees
• More than one plane defirmity
• Age 10 - 16 yrs

• Range of motion:

  1. Full extension
  2. More than 100 in flextion

Exclusion Criteria:

• Genu recurvatum.
• Flexion deformity.
• Pathological conditions (e.g: bone softening diseases
• Dysplasia
• Limb length discrepancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group	Procedure: correction of deformities around the knee with external fixator; minimally invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoresen scoring system	Malaligment varus/valgus procurvatum/retrocurvatum internal/external rotation; Range of motion flextion extension deficit pain and swelling	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Espandar R, Mortazavi SM, Baghdadi T. Angular deformities of the lower limb in children. Asian J Sports Med. 2010 Mar;1(1):46-53. doi: 10.5812/asjsm.34871.
• Edgerton BC, Mariani EM, Morrey BF. Distal femoral varus osteotomy for painful genu valgum. A five-to-11-year follow-up study. Clin Orthop Relat Res. 1993 Mar;(288):263-9.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Soh-Med-22-03-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No