Humeral FracturesNCT00358787
Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires
A study testing Crossed K-wiring of supracondylar fracture of the humerus and Lateral K-wiring of supracondylar fracture of the humerus in people with Humeral Fractures, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Crossed K-wiring of supracondylar fracture of the humerus and Lateral K-wiring of supracondylar fracture of the humerus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: 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.
Read the 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.
- Conditions
- Humeral Fractures
- Being tested
- Crossed K-wiring of supracondylar fracture of the humerus, Lateral K-wiring of supracondylar fracture of the humerus
- Keywords
- Supracondylar fracture, humerus, ulnar nerve injury, Baumann's angle, Supracondylar fracture of the humerus
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crossed K-wiring of supracondylar fracture of the humerusProcedure or surgery
Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
Lateral K-wiring of supracondylar fracture of the humerusProcedure or surgery
Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Crossed K wire orientation for surgical management of a type III Supracondylar fracture. Receives: Procedure: Crossed K-wiring of supracondylar fracture of the humerus |
| 2 | Active comparator | Lateral K wire orientation for surgical management of a type III Supracondylar fracture. Receives: Procedure: Lateral K-wiring of supracondylar fracture of the humerus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
Secondary outcomes (2)
Functional outcome (3 years post-op)
Measured: 3 years
Rate of iatrogenic ulnar nerve injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2008
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishore Mulpuri, University of British Columbia
- Investigators
- Kishore Mulpuri, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358787
- Sponsor's protocol ID
- H04-70532
- Other IDs
- W04-0180
- Status last verified
- Jan 2018
- First submitted
- 28 Jul 2006
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00358787
- Acronym / sponsor ID
- H04-70532
- Conditions
- Humeral Fractures
- Keywords
- Supracondylar fracture, humerus, ulnar nerve injury, Baumann's angle, Supracondylar fracture of the humerus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Crossed K-wiring of supracondylar fracture of the humerusCrossed K wire orientation for surgical management of a type III Supracondylar fracture. |
| 2 | Active comparator | Procedure: Lateral K-wiring of supracondylar fracture of the humerusLateral K wire orientation for surgical management of a type III Supracondylar fracture. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crossed K-wiring of supracondylar fracture of the humerusClosed reduction of the fracture followed by crossed K wire percutaneous pinning. | Procedure or surgery | 1 |
| Lateral K-wiring of supracondylar fracture of the humerusClosed reduction of the fracture followed by lateral K wire percutaneous pinning. | Procedure or surgery | 2 |
Primary outcome
Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
2 secondary outcomes
Functional outcome (3 years post-op)
Time frame: 3 years
Rate of iatrogenic ulnar nerve injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kishore Mulpuri, MD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crossed K-wiring of supracondylar fracture of the humerus and Lateral K-wiring of supracondylar fracture of the humerus in people with Humeral Fractures, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.