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Completed

NCT Number: NCT04423835

Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children

Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.

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Key information

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

About this study

Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric fractures in children. Poorly treated SHFs can lead to the most common cubitus varus deformity especially in patients treated conservatively. The cosmetic aspect of this deformity is the main concern of patients, together with reduced remodeling ability. Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and fixation materials have been developed in the last several decades. With the advent of three-dimensional printing techniques and computed tomography reconstruction methods, more accurate computing designs have been applied in the correction of cubitus varus. These techniques make the surgery more complex and require the performance of computed tomography (CT), resulting in high radiation exposure in children. Paley described the principles of deformity correction that are widely used for the lower limbs. These principles represent an alternative with easy application without the need of CT, with less occurrence of prominence and good cosmetic outcome. According to the Paley principles, all the vertex of the triangular osteotomy should site on the center of rotation of angulation (CORA) line, by doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to accurately correct the anatomic axis of the upper limb. According to our knowledge, this is the first study describes the lateral closing wedge osteotomy for correction cubitus varus deformity in children by applying Paley's principles and fixation with K-wires.

Taken together, the investigators aimed at verifying the feasibility of Paley's principles for deformity correction to treat cubitus varus in children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • surgery performed over 6 months after the occurrence of SHFs
  • difference in flexion angles of the affected and unaffected limbs of >15 degrees
  • recovery of elbow function pre-ostomy

Exclusion criteria

  • any other surgical approach used
  • consent not obtained from the patient's guardians
  • incomplete follow-up

Treatment and study plan

Paley's Principle osteotomy

Procedure

. The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.

Other names: Applying Paley's Principles to Lateral Closing Wedge Osteotomy

Primary outcomes

  1. Elbow appearance

    Time frame: 3th month after surgery

    elbows were evaluated using radiography and appearence

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Registry information

Official study title

Applying Paley's Principles to Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Jun 11, 2020

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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