NCT04752995

Brief Summary

Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

February 9, 2021

Last Update Submit

February 10, 2021

Conditions

Keywords

Genu varum, mini-invasive, osteotomy, osteoclasis

Outcome Measures

Primary Outcomes (3)

  • proximal medial tibial angle

    This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction

    one year

  • the posterior proximal tibial angle

    confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)

    one year

  • Self-Administered Patient Satisfaction Scale

    the investigators asked the parents to rate their satisfaction on a scale from zero to 100 (100 to 75 very satisfied, \<75 to 50 somewhat satisfied, \<50 to 25 somewhat dissatisfied and \<25 dissatisfied).Those who were not satisfied are requested to explain the cause of dissatisfaction.

    one year

Study Arms (1)

high tibial osteotomy

OTHER

Under general anesthesia, a one-cm vertical skin incision was done at the medial subcutaneous border of the tibia, one fingerbreadth below the tibial tuberosity. This was confirmed by intra-operative C-arm images. Longitudinal periosteal incision was done with minimal dissection. Incomplete medial transverse osteotomy including both anterior and posterior cortex was performed using drill bit or small thin osteotome.Osteotomy was completed manually by osteoclasis of the lateral cortex to provide postoperative stability by the preserved lateral periosteum. No fibular osteotomy was needed in the present study.

Procedure: osteotomy

Interventions

osteotomyPROCEDURE

osteotomy osteoclasis of upper tibia

high tibial osteotomy

Eligibility Criteria

Age36 Months - 52 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infantile genu-varum
  • PMTA≤70 not spontaneously corrected

You may not qualify if:

  • Active rickets or other metabolic disease
  • Patients in whom the femur or the joint is the main site of the deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rab GT. Oblique tibial osteotomy revisited. J Child Orthop. 2010 Apr;4(2):169-72. doi: 10.1007/s11832-009-0228-z. Epub 2009 Dec 20.

    PMID: 20234769BACKGROUND

MeSH Terms

Conditions

Genu Varum

Interventions

Osteotomy

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 12, 2021

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

January 1, 2016

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

the investigators will publish the final results