Tibia Fracture
Conditions
Keywords
intramedullary nail, weight-bearing
Brief summary
Aim of our study is to compare immediate full weight-bearing and partial weight-bearing for 6 weeks after a tibial shaft fracture treated with intramedullary nailing. Co-primary outcome is return to work and physical component scale in the SF-36 questionnaire.
Interventions
PROCEDUREFull weight-bearing
Instruction for full and immediate weight-bearing postoperatively
PROCEDUREPartial weight-bearing
Instruction for partial weight-bearing for 6 weeks postoperatively
PROCEDUREIntramedullary nailing
Intramedullary nailing of the fractured tibial shaft.
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* AO/OTA 42-A/B acute, noncomminuted diaphyseal fracture of the tibia treated with intramedullary nailing with or without posterior malleolus screw fixation * operated within 72 hours of admittance * age between 18-65 years
Exclusion criteria
* the inability to fill out the Finnish versions of the questionnaires * previous arthroplasty of the knee or the ankle of the fractured limb * previous ipsilateral below-knee fracture requiring surgical treatment or ankle arthrodesis * inability to co-operate * not living independently (institutionalized living before fracture) * open fracture (Gustilo grade 2 or over) * pathologic or stress fracture * multiple fractures requiring operative treatment in polytrauma patient * severe medical comorbidity impairing daily activities (inability to go climb three floors without assistance and stopping) * Body Mass Index over 40 * unacceptably high risk of surgery due to severe medical comorbidities * severe substance abuse * patient is retired * age is less than 18 or more than 65 * patient required a fasciotomy due to acute compartment syndrome during or after index surgery * inability to walk before fracture or a daily need of walking aid, such as crutches
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical component summary | 3 months | Physical component summary of the SF-36 questionnaire |
| Return to work | 3 months | Rate of return to work |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical component summary | 6 months | Physical component summary of the SF-36 questionnaire |
| Total sick leave | 12 months | Overall length of sick leave |
| Lower extremity functional scale | 3 months | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). |
| Tegner activity level scale | 3 months | Method of grading work and sporting activities |
| University of California and Los Angeles activity level scale | 3 months | Method of grading work and sporting activities |
| Complications | 6 weeks | Surgery related complications |
| 36-Item Short Form Survey | 3 months | — |
| Return to work | 6 months | Rate of return to work |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total ground force during gait | 3 weeks | Measurement of lower leg activity using pressure insoles |
Countries
Finland
Contacts
Primary ContactAleksi Reito, Assoc prof
Backup ContactSatu Ylä-Mononen
Outcome results
None listed