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Pediatric Type III Supracondylar Humeral Fracture (Fracture)

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ClinicalTrials.gov Identifier: NCT04780308
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Alkan Bayrak, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary:
The purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF).

Condition or disease Intervention/treatment
Supracondylar Humerus Fracture Pediatric Fractures Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires

Detailed Description:
The study consisted of 100 (68M, 32F) children who underwent surgery between 2010 and 2013 for Gartland Type 3 (SCHF). The patients divided into five groups according to the top in configurations (crossed 1 lateral 1 medial, crossed 2 lateral 1 medial, crossed 1 lateral 2 medial, 2 lateral divergent, and 3 lateral divergent). The average age at the time of injury was 7.34 (between 2 and 14 years). Bauman angle (BA), Humerocapital angle (HCA), Anterior humeral line (AHL), flexion range, extension range, and Carrying angle (CA) were compared at preoperative, postoperative 1st-day, postoperative last control, and non-operated side. The mean follow-up time 24,96±11,06 with a range of 12-54 months.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: How Many K Wires do we Need in the Surgical Treatment of Pediatric Type III Supracondylar Humeral Fracture?
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : February 20, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1 medial 1 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 1 lateral K-wire
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.

1 medial 2 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 2 lateral K-wire
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.

2 medial 1 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 medial 1 lateral K-wire
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.

2 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 lateral K-wire
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.

3 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 3 lateral K-wire
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.




Primary Outcome Measures :
  1. Baumann Angle [ Time Frame: postoperative 1. day, 1. month and 12. month ]
    This angle is formed by the humeral axis and a straight line through the epiphyseal plate of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.

  2. Anterior Humeral Line [ Time Frame: postoperative 1. day, 1. month and 12. month ]
    A line drawn down the anterior surface of the humerus should intersect the middle third of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.

  3. Humero-Capital Angle [ Time Frame: postoperative 1. day, 1. month and 12. month ]
    On lateral X-ray angle between capitellum and humeral shaft. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients under 16 years.
Criteria

Inclusion Criteria

  • Pediatric Gartland Type 3 supracondylar humeral fracture
  • Patients operated between 2010-2013
  • Patients under 16 years old

Exclusion Criteria:

  • Pathological fractures
  • Conservative treated supracondylar fractures
  • Less than the 1-year follow-up
  • Patients with incomplete postoperative follow-up
  • Patients older than 16 years
  • Pediatric Gartland Type 1 and 2 supracondylar humeral fracture
  Study Documents (Full-Text)

Documents provided by Alkan Bayrak, Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
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Responsible Party: Alkan Bayrak, Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT04780308    
Other Study ID Numbers: 2014/18/05
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkan Bayrak, Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
pediatric
supracondylar humeral fracture
k wires
closed reduction
pin configuration
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries