Open tíbia Fracture
Conditions
Brief summary
The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.
Detailed description
The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function. This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.
Interventions
PROCEDUREMinimally Invasive Locking Plate Fixation
Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
PROCEDUREIntramedullary Nail Fixation
Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.
Sponsors
Taizhou Hospital
Ningbo No.2 Hospital
The First People's Hospital of Huzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18 - 60 years inclusive * Open diaphyseal fracture * Gustilo-Anderson Type I, II, IIIA
Exclusion criteria
* Closed, periarticular or pathological fracture * Gustilo-Anderson Type IIIB,IIIC * Patients with concomitant fractures in the ipsilateral limb * The patient is unable to medically tolerate general anesthesia * The patient is unable to provide informed consent or comply with completing questionnaires * Tibia already infected as diagnosed by a surgeon * The patient has been diagnosed with a severe psychiatric condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LEFS | 12 months | failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 12 months | Reported Outcome and Quality of Life |
Other
| Measure | Time frame | Description |
|---|---|---|
| SF-12 | 12 months | Reported Outcome and Quality of Life |
| Fracture Healing | 12 months | Fracture healing is measured by the treating surgeon using standard clinical criteria. |
| Complications | 12 months | Soft tissue complications |
Contacts
Primary ContactZhao-ming Ye, MD
Backup ContactLing-ling Sun, MD
Outcome results
None listed