Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

Study Overview
=================
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

Detailed Description
-----------------
Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.

Official Title
-----------------
Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum: Improving the Technique and Managing Potential Complications.

Conditions
-----------------
Deformity Knee, Deformity of Limb

Intervention / Treatment
-----------------
* Procedure: osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Infantile genu-varum PMTA≤70 not spontaneously corrected Exclusion criteria: Active rickets or other metabolic disease Patients in whom the femur or the joint is the main site of the deformity

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 52 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: high tibial osteotomy<br>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<br>* osteotomy osteoclasis of upper tibia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genu varum, mini-invasive, osteotomy, osteoclasis