Fractures of Radius and Ulna
Conditions
Keywords
fractures of both radius and ulna
Brief summary
The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points: 1. a lower rate of implant pain 2. a lower re-operation rate to remove painful hardware.
Detailed description
This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.
Interventions
PROCEDUREintramedullary nailing and plating
Surgical intramedullary nailing of the ulna and plating of the radius
PROCEDUREplating
Surgical plating of both bonforearm fractures
Sponsors
Florida Orthopaedic Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diaphyseal fractures of both radius and ulna * Ulna fractures that are oblique or transverse * Fractures may be closed or Grade I-IIIA open * Patients must be over 18 and skeletally mature
Exclusion criteria
* Children under the age of 18 * Pregnancy * Comminuted ulna fractures * Those with associated bony elbow or wrist trauma * Elbow dislocation * Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implant pain | 1 year | a visual analog scale (VAS) will be used to assess pain in the forearm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-operation rate to remove painful hardware | 1 year | repeat surgical intervention will be captured |
Countries
United States
Outcome results
None listed