Clinical trial NCT04640727: ORIF Versus CRIF of Completely Displaced and Rotated Lateral Condylar Fractures of the Humerus in Children
Official title: ORIF Versus CRIF of Completely Displaced and Rotated Lateral Condylar Fractures of the Humerus in Children：a Ambispective Chort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Humeral Fractures
Keywords: Open reduction and internal fixation
Closed reduction and internal fixation
completely displaced and rotated lateral condylar fracture
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After Internal Review Board approval, all Type III lateral condyle fractures according to Jakob classification were reviewed at our institution from 2017 to 2021

Brief summary: Open reduction and internal fixation has been widely used in treating completely displaced and rotated lateral condylar fracture in children and it usually produces good results. Only a few studies reported Closed reduction and internal fixation is an effective treatment for completely displaced and rotated lateral condyle fractures of the humerus, but evidence on its effectiveness and safety is scarce. The aim of the trial was to compare functional and outcome use in patients treated completely displaced and rotated lateral condylar fracture with ORIF versus CRIF.

Detailed description: Lateral condylar humerus fractures are the second most common elbow fracture in children, accounting for approximately 17-20% of pediatric elbow fractures. Jakob et al. first described a novel classification based on the presence of cartilage bridging. It was modified by Foster et al. who identified the differences in outcomes between fractures with \< 2 mm and ≥ 2 mm displacement. most surgeons preferred open reduction and internal fixation (ORIF) to insure anatomic reduction of these unstable intra-articular fractures. Only a few reports have focused on closed reduction and Percutaneous Pinning (CRPP) of lateral condylar humeral fractures. In most studies, this technique was used only in cases with displacement between 2 and 4mm. CRPP has shown several advantages over ORIF, including less dissection of soft tissue around the fragment, low risk of vessel damage, low risk of non-union and avascular necrosis (AVN) of distal humerus physeal, shorter operating room times, and avoidance of an open incision with an unaesthetic scar. Song et al. introduced a new classification and an internal oblique view to better assess the displacement of the fragment, and they managed to achieve closed reduction of the fracture, even in cases with displacement exceeding 4mm or those with rotational displacement (graded as stage 5 according Song classification and Type III according to Jakob classification). Because the study was not controlled, we could not tell the difference between cases treated with CRPP and the cases treated with ORIF directly.

Since May 1, 2019, at our Institution, we have been treating type III lateral condyle fractures with CRPP. The primary objective of this study was to report the efficacy and safety of CRPP of lateral condyle fracture. The secondary aim was to compare the outcomes between CRPP and ORIF.

Eligibility criteria: Inclusion Criteria:

* completely displaced and rotated lateral condyle fractures of the humerus (Jakob Stage 3)

Exclusion Criteria:

- presented more than 7 days after the fracture , Capitulum humerus cannot be clearly identified on X-ray， had experienced a previous lateral condyle fractures on the same limbs, pathological fracture， open fracture， Combined with other fractures at the same time，

Primary outcomes:
measure: Hardacre criteria
timeFrame: 1 years follow up
Secondary outcomes:
measure: duration of operation
timeFrame: during the operation
measure: amount of bleeding
timeFrame: during the operation
measure: Radiation exposure
timeFrame: during the operation
measure: The interepicondylar width (IEW)
timeFrame: 3 months after the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women & Children Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women & Children Medical Center
name: Hongwen Xu, doctor
role: PRINCIPAL_INVESTIGATOR
References: