Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

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

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

Study Overview

• Status: Completed
• Conditions: Deformity of Limb; Deformity Knee
• Intervention / Treatment: Procedure: osteotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: high tibial osteotomy; 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; osteotomy osteoclasis of upper tibia

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

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Genu varum, mini-invasive, osteotomy, osteoclasis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Congenital Abnormalities; Genu Varum
• Other Study ID Numbers: Tanta u

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the investigators will publish the final results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No