Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT04752995

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Deformity Knee Deformity of Limb	Procedure: osteotomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective randomized studyprospective randomized study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

proximal medial tibial angle [one year]
This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction
the posterior proximal tibial angle [one year]
confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)
Self-Administered Patient Satisfaction Scale [one year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Months to 52 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

ahmed m. samy, assisstant professor, Tanta University

ClinicalTrials.gov Identifier:

NCT04752995

Other Study ID Numbers:

Tanta u

First Posted:

Feb 12, 2021

Last Update Posted:

Feb 12, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ahmed m. samy, assisstant professor, Tanta University

Genu varum, mini-invasive, osteotomy, osteoclasis

Additional relevant MeSH terms:

Genu Varum

Congenital Abnormalities

Study Results

No Results Posted as of Feb 12, 2021