Clinical trial NCT05151926: Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tibia Fracture
Keywords: intramedullary nail
weight-bearing
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Return to work
timeFrame: 3 months
measure: Physical component summary
timeFrame: 3 months
Secondary outcomes:
measure: Return to work
timeFrame: 6 months
measure: Return to work
timeFrame: 12 months
measure: Physical component summary
timeFrame: 6 months
measure: Physical component summary
timeFrame: 12 months
measure: Total sick leave
timeFrame: 12 months
measure: Lower extremity functional scale
timeFrame: 3 months
measure: Lower extremity functional scale
timeFrame: 6 months
measure: Lower extremity functional scale
timeFrame: 12 months
measure: Lower extremity functional scale
timeFrame: 24 months
measure: 36-Item Short Form Survey
timeFrame: 3 months
measure: 36-Item Short Form Survey
timeFrame: 6 months
measure: 36-Item Short Form Survey
timeFrame: 12 months
measure: 36-Item Short Form Survey
timeFrame: 24 months
measure: Tegner activity level scale
timeFrame: 3 months
measure: Tegner activity level scale
timeFrame: 6 months
measure: Tegner activity level scale
timeFrame: 12 months
measure: Tegner activity level scale
timeFrame: 24 months
measure: University of California and Los Angeles activity level scale
timeFrame: 3 months
measure: University of California and Los Angeles activity level scale
timeFrame: 6 months
measure: University of California and Los Angeles activity level scale
timeFrame: 12 months
measure: University of California and Los Angeles activity level scale
timeFrame: 24 months
measure: Complications
timeFrame: 6 weeks
measure: Complications
timeFrame: 3 months
measure: Complications
timeFrame: 6 months
measure: Complications
timeFrame: 12 months
measure: Complications
timeFrame: 24 months
Other outcomes:
measure: Total ground force during gait
timeFrame: 3 weeks
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Hospital Nova
state: Keski-Suomi
city: Tampere
country: Finland
facility: Tampere Univeristy Hospital
state: Pirkanmaa
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Tampere University Hospital
name: Aleksi Reito, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References: