| July 28, 2006 |
| July 14, 2008 |
| July 2008 |
| December 2010 (final data collection date for primary outcome measure) |
| Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal) [ Time Frame: Unspecified ] [ Designated as safety issue: No ] |
| Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal) |
| Complete list of historical versions of study NCT00358787 on ClinicalTrials.gov Archive Site |
- Functional outcome (3 years post-op) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Rate of iatrogenic ulnar nerve injury [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
|
- Functional outcome (3 years post-op)
- Rate of iatrogenic ulnar nerve injury
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| |
| Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-Wires |
| Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Humeral Fractures |
- Procedure: Crossed K-wiring of supracondylar fracture of the humerus
- Procedure: Lateral K-wiring of supracondylar fracture of the humerus
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- Active Comparator: Supracondylar fracture of the humerus will be reduced and fixed percutaneously with crossed K wires.
- Active Comparator: Supracondylar fracture of the humerus will be reduced and fixed percutaneously with lateral K wires.
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| |
| |
| Recruiting |
| 42 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 3 Years to 7 Years |
| Yes |
|
|
| Canada |
| |
| NCT00358787 |
| Dr. Kishore Mulpuri, University of British Columbia |
| C04-0532, W04-0180 |
| University of British Columbia |
|
| Principal Investigator: |
Kishore Mulpuri, MD |
The University of British Columbia |
|
|
| University of British Columbia |
| July 2008 |