Correction of Multiplanar Deformities Around the Knee Wit... | NCT05331677

Studies
Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

NCT05331677

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 18, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Deformities Around the Knee in Pedietrics

Interventions

correction of deformities around the knee with external fixator

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2022Estimated

Primary Completion Date

Apr 2023Estimated

Completion Date

Apr 2023Estimated

First Submitted Date

Mar 18, 2022

First Submission Date that Met QC Criteria

Apr 10, 2022

First Posted Date

Apr 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2022

Last Update Posted Date

Apr 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

mohamed mahmoud eldeeb, resident doctor at othopedic surgery department, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental		Procedure: correction of deformities around the knee with external fixator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
correction of deformities around the knee with external fixator	Procedure	minimally invasive surgery	study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed m eldeeb, resident doctor	Contact	01062851905		mohamed011166@med.sohag.edu.eg
Ahmed i addosooki, professor	Contact	01011110232

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Hospital		Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22375192	Background	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.
8458142	Background	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.

Type	Date	Date Unknown
Release	May 10, 2023
Reset	Jan 26, 2024

ID	Term
D009984	Orthopedic Fixation Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies