Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

• Sponsor: Sohag University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05331677
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Deformities Around the Knee in Pedietrics	Procedure: correction of deformities around the knee with external fixator	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Thoresen scoring system [one year]

   Malaligment varus/valgus procurvatum/retrocurvatum internal/external rotation Range of motion flextion extension deficit pain and swelling

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University Hospital	Sohag		Egypt

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Espandar R, Mortazavi SM, Baghdadi T. Angular deformities of the lower limb in children. Asian J Sports Med. 2010 Mar;1(1):46-53.

• Responsible Party: mohamed mahmoud eldeeb, resident doctor at othopedic surgery department, Sohag University
• ClinicalTrials.gov Identifier: NCT05331677
• Other Study ID Numbers: Soh-Med-22-03-07
• First Posted: Apr 18, 2022
• Last Update Posted: Apr 18, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Apr 18, 2022