Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum
1 other identifier
interventional
70
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Typical duration for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedFebruary 12, 2021
February 1, 2021
2.5 years
February 9, 2021
February 10, 2021
Conditions
Keywords
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
OTHERUnder 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.
Interventions
Eligibility Criteria
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
- Tanta Universitylead
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- 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