Clinical trial NCT04423835: Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children
Official title: Applying Paley's Principles to Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deformity; Bone
Keywords: cubitus varus
supracondylar humerus fracture
osteotomy
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 21
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients were performed surgery between July 2015 and October 2017

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Elbow appearance
timeFrame: 3th month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: