Forearm Fracture, Intramedullary Nail, Plate Fixation, Randomized Controlled Trial
Conditions
Keywords
forearm fractures, pediatric fractures, flexible nail, plate fixation
Brief summary
A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.
Interventions
DEVICEDual intramedullary nailing
\- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique.
DEVICEDual plating
\- ORIF for radius done first through volar approach.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both-bone Forearm Diaphyseal Fracture. 2. age more than or equal nine years old with open distal radius physis. 3. Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.
Exclusion criteria
1. Neurovascular injury. 2. Open fractures 3. Comminuted fractures 4. Pathological fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction questionnaire | 6 months | five points Likert scale |
| Time to union | 6 months | weeks required to achieve union |
| Elbow range of motion | 6 months | elbow flexion, extension, pronation and supination in degrees |
| Quick DASH score | 6 months | Patient reported questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 months | Any adverse event will be recorded |
| Re-operation rate | 6 months | percentage of patients requiring reoperation |
| size of wound scar in millimeters | 6 months | measuring the size of wound scar in millimeters |
| Deformity (malunion rate) | 6 months | Malunion deformity |
Countries
Egypt
Outcome results
None listed