Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Study Overview
=================
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.

Official Title
-----------------
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF): a Protocol for Prospective, Randomized,Multicentre Trial Comparing the Early Partial and Early Full Weightbearing After Nailed Tibial Shaft Fracture

Conditions
-----------------
Tibia Fracture

Intervention / Treatment
-----------------
* Procedure: Full weight-bearing
* Procedure: Partial weight-bearing
* Procedure: Intramedullary nailing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full weight-bearing<br>Full immediate weight-bearing postoperatively | Procedure: Full weight-bearing<br>* Instruction for full and immediate weight-bearing postoperatively<br>Procedure: Intramedullary nailing<br>* Intramedullary nailing of the fractured tibial shaft.<br>|
| Active Comparator: Partial-weight bearing<br>Partial weight-bearing for the first 6 weeks postoperatively. | Procedure: Partial weight-bearing<br>* Instruction for partial weight-bearing for 6 weeks postoperatively<br>Procedure: Intramedullary nailing<br>* Intramedullary nailing of the fractured tibial shaft.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Rate of return to work | 3 months | 
| Physical component summary | Physical component summary of the SF-36 questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Rate of return to work | 6 months | 
| Return to work | Rate of return to work | 12 months | 
| Physical component summary | Physical component summary of the SF-36 questionnaire | 6 months | 
| Physical component summary | Physical component summary of the SF-36 questionnaire | 12 months | 
| Total sick leave | Overall length of sick leave | 12 months | 
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 3 months | 
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 6 months | 
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 12 months | 
| Lower extremity functional scale | Measurement of lower extremity function with a scale from 0 (worst) to 100 (best). | 24 months | 
| 36-Item Short Form Survey |  | 3 months | 
| 36-Item Short Form Survey |  | 6 months | 
| 36-Item Short Form Survey |  | 12 months | 
| 36-Item Short Form Survey |  | 24 months | 
| Tegner activity level scale | Method of grading work and sporting activities | 3 months | 
| Tegner activity level scale | Method of grading work and sporting activities | 6 months | 
| Tegner activity level scale | Method of grading work and sporting activities | 12 months | 
| Tegner activity level scale |  | 24 months | 
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 3 months | 
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 6 months | 
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 12 months | 
| University of California and Los Angeles activity level scale | Method of grading work and sporting activities | 24 months | 
| Complications | Surgery related complications | 6 weeks | 
| Complications | Surgery related complications | 3 months | 
| Complications | Surgery related complications | 6 months | 
| Complications | Surgery related complications | 12 months | 
| Complications | Surgery related complications | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intramedullary nail, weight-bearing