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Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires

Primary Purpose

Humeral Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Crossed K-wiring of supracondylar fracture of the humerus
Lateral K-wiring of supracondylar fracture of the humerus
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fractures focused on measuring Supracondylar fracture, humerus, ulnar nerve injury, Baumann's angle, Supracondylar fracture of the humerus

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients scheduled for closed reduction and K wiring of supracondylar fractures of the humerus under general anaesthesia a Type-3 Supracondylar fractures of the humerus. Aged 3 to 7 years old Consent to participate in the study Exclusion Criteria: Open supracondylar fractures of the humerus Children with pre-operative ulnar nerve injury Supracondylar fractures with compartment syndrome needing fasciotomy Supracondylar fractures needing vascular repair Refusal to provide informed consent

Sites / Locations

  • British Columbia Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Crossed K wire orientation for surgical management of a type III Supracondylar fracture.

Lateral K wire orientation for surgical management of a type III Supracondylar fracture.

Outcomes

Primary Outcome Measures

Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)

Secondary Outcome Measures

Functional outcome (3 years post-op)
Rate of iatrogenic ulnar nerve injury

Full Information

First Posted
July 28, 2006
Last Updated
January 8, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00358787
Brief Title
Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires
Official Title
Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Completely displaced (Type III) supracondylar fractures of the humerus are treated in the operating room and are held together with pins stuck into the bone. There are two ways of inserting the pins: crossed and laterally. The crossed method is often used because it is thought to be more stable, but this method also carries a risk of hitting the ulnar nerve. It is not known which method is more stable. Our hypothesis is that loss of reduction will be equivalent between the two pinning methods.
Detailed Description
Children with type III supracondylar fractures of humerus who meet the study inclusion criteria will be invited to participate in the study by the on call orthopaedic surgeon. All patients will be required to provide informed consent. Patients will then be randomized through a random number software package and will commence immediately after confirmation of inclusion into the study. The fracture is reduced and fixed percutaneously either with crossed or lateral K wires, according to which group the subject was randomized to. Post reduction antero-posterior and lateral radiographs of the elbow are done in the operating room. Above elbow cast is applied. Radiographs are taken at follow-up visits to the clinic. The radiographs are measured to determine loss of reduction between immediate post-op films and films taken immediately prior to pin removal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures
Keywords
Supracondylar fracture, humerus, ulnar nerve injury, Baumann's angle, Supracondylar fracture of the humerus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Crossed K wire orientation for surgical management of a type III Supracondylar fracture.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Lateral K wire orientation for surgical management of a type III Supracondylar fracture.
Intervention Type
Procedure
Intervention Name(s)
Crossed K-wiring of supracondylar fracture of the humerus
Intervention Description
Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
Intervention Type
Procedure
Intervention Name(s)
Lateral K-wiring of supracondylar fracture of the humerus
Intervention Description
Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
Primary Outcome Measure Information:
Title
Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
Secondary Outcome Measure Information:
Title
Functional outcome (3 years post-op)
Time Frame
3 years
Title
Rate of iatrogenic ulnar nerve injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients scheduled for closed reduction and K wiring of supracondylar fractures of the humerus under general anaesthesia a Type-3 Supracondylar fractures of the humerus. Aged 3 to 7 years old Consent to participate in the study Exclusion Criteria: Open supracondylar fractures of the humerus Children with pre-operative ulnar nerve injury Supracondylar fractures with compartment syndrome needing fasciotomy Supracondylar fractures needing vascular repair Refusal to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore Mulpuri, MD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

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Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires

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