Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

Deformity of Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752995
• Other study ID #: Tanta u
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 52 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Deformity Knee
• Deformity of Limb
• Genu Varum

Intervention

Procedure:
• osteotomy
osteotomy osteoclasis of upper tibia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the posterior proximal tibial angle	confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)	one year
Primary	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