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Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Primary Purpose

Deformities Around the Knee in Pedietrics

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

correction of deformities around the knee with external fixator

About this trial

This is an interventional treatment trial for Deformities Around the Knee in Pedietrics

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sohag University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

Outcomes

Primary Outcome Measures

Thoresen scoring system

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05331677

First Posted

March 18, 2022

Last Updated

April 10, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05331677

Brief Title

Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Official Title

Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2022 (Anticipated)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deformities Around the Knee in Pedietrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

correction of deformities around the knee with external fixator

Intervention Description

minimally invasive surgery

Primary Outcome Measure Information:

Title

Thoresen scoring system

Description

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Full extension More than 100 in flextion Exclusion Criteria: Genu recurvatum. Flexion deformity. Pathological conditions (e.g: bone softening diseases Dysplasia Limb length discrepancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mohamed m eldeeb, resident doctor

Phone

01062851905

mohamed011166@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed i addosooki, professor

Phone

01011110232

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama R ELsheref, professor

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

22375192

Citation

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.

Results Reference

background

PubMed Identifier

8458142

Citation

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.

Results Reference

background

Learn more about this trial

Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

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