Displaced Forearm Fractures Clinical Trial
Official title:
Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
| Verified date | September 2014 |
| Source | Children's Hospital Boston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.
| Status | Completed |
| Enrollment | 202 |
| Est. completion date | August 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 16 Years |
| Eligibility |
Inclusion Criteria: - Displaced distal radius or mid-diaphyseal forearm fracture - fracture requires closed reduction and cast immobilization - Age 4-16 years - Skeletally immature Exclusion Criteria: - Failed closed reduction - Acute fracture > 1 week old - Refracture injury - Fracture requires surgical treatment - Significant soft tissue swelling - Associated neurovascular compromise - Plastic deformation injuries |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Childrens Hospital Boston | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Boston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Loss of Radius Fracture Reduction | The number of participants that experienced radiographic loss of reduction by four weeks post-randomization. | 4 weeks post-randomization | No |
| Secondary | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization. | Up to 4 weeks post-randomization | Yes |