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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04582123
Other study ID # 2014/250
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2015
Est. completion date January 24, 2020

Study information

Verified date October 2020
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.


Description:

Fortyfive children with supracondylar humeral fractures were randomly divided into two groups. One group was treated with 2 crossed pins and the other group with 3 crossed pins. The mean age was 6.04±2.49 (1-12).. The follow-up period was 5 years, with no patients lost to follow up.

Intervention: Twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method. All surgeries were performed by the same surgeon.

Main Outcome Measurements: Postoperative stability, ulnar nerve injury, range of motions, and pin tract infections were evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 24, 2020
Est. primary completion date January 24, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria:

- The inclusion criteria was children with closed extension Type III of supracondylar fracture of humerus.

Exclusion Criteria:

- Patients with Type I and Type II injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.

Study Design


Intervention

Procedure:
crossed pin configuration
comparison of two crossed pin fixation methods

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary functional outcome of two fixation techniques comparison of Flynn's criteria 5 years
See also
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Not yet recruiting NCT05780398 - Long Term Follow up in Pediatric Supracondylar Humeral Fracture
Completed NCT00871793 - Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures N/A
Terminated NCT04905563 - NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures Phase 4
Recruiting NCT04288206 - Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial N/A
Completed NCT04780308 - Pediatric Type III Supracondylar Humeral Fracture
Recruiting NCT03759028 - Supracondylar Post-Operative Pain Study Phase 4
Completed NCT01808183 - Pediatric Supracondylar Humerus Fracture NIRS Study
Completed NCT03261830 - Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS) Phase 4
Recruiting NCT04122781 - Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices N/A
Enrolling by invitation NCT06187584 - SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management Phase 4