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NCT Number: NCT04752995

Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

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

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Key information

Conditions

Deformity Knee Bone Diseases Deformity of Limb Genu Varum Musculoskeletal Diseases

Age range

36 month–52 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

osteotomy

Procedure

osteotomy osteoclasis of upper tibia

Primary outcomes

  1. proximal medial tibial angle

    Time frame: one year

    This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction

  2. the posterior proximal tibial angle

    Time frame: one year

    confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)

  3. Self-Administered Patient Satisfaction Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 12, 2021
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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