Recruiting

Operative vs. Non-Operative

Sponsor:

British Columbia Children's Hospital

Code:

NCT02963233

Conditions

Trauma

Fracture;Elbow

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

Interventions

Closed reduction and percutaneous pinning and immobilization

Non-operative reduction and immobilization

Study Details

Brief summary:

The treatment of pediatric supracondylar humerus fractures is controversial, but despite the injury's high incidence there is a lack of high level evidence to guide operative versus non-operative decision making for displaced fractures with an intact posterior cortex (Gartland Type II). This study aims to prospectively compare clinical, functional, and radiographic outcomes between operatively and non-operatively treated patients using a prospective multi-centre cohort design.

Conditions

Trauma

Fracture;Elbow

Study ID

NCT02963233

Start date

Jul, 2015

Status verified date

Nov, 2016

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 2-12 years
  • Isolated supracondylar humerus fracture
  • Gartland Type II extension-type fracture
  • Closed injury

Exclusion Criteria:

  • Neurovascular compromise
  • Underlying musculoskeletal disorder

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-operative Group

Patients treated within the non-operative group will be treated with gentle reduction by the orthopaedic surgery team in the emergency department under procedural sedation. Immobilization and maintenance of reduction will be obtained through either taping of the elbow in a flexed (100-110 degree) and pronated position or through long-arm casting at 90 degrees of flexion. Immobilization type and position will be noted.

Operative Group

Patients treated operatively will be largely treated with closed reduction and percutaneous pinning with 2-3 laterally-based k-wires, followed by long-arm immobilization. Immobilization type and position will be noted.

Interventions

Closed reduction and percutaneous pinning and immobilization

Non-operative reduction and immobilization

Primary outcome measure

  • Change in Lateral Humerocapitellar Angle [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Tammie Teo

6048752359Tammie.Teo@cw.bc.ca

Emily Schaeffer, PhD

6048752359Emily.Schaeffer@cw.bc.ca

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Tammie Teo

6048752359Tammie.Teo@cw.bc.ca

Emily Schaeffer, PhD

6048752359Emily.Schaeffer@cw.bc.ca

Principal Investigator:

Christopher Reilly, MD, FRCSC

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Sasha Carsen, MD, MBA, FRCSC

6137377600SCarsen@cheo.on.ca

Principal Investigator:

Sasha Carsen, MD, MBA, FRCSC

More Information

Sponsor

British Columbia Children's Hospital

Last update posted

Nov 15, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Children's Hospital on 2016-11-15.