Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
NCT ID: NCT05151926
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2021-12-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Full weight-bearing
Full immediate weight-bearing postoperatively
Full weight-bearing
Instruction for full and immediate weight-bearing postoperatively
Intramedullary nailing
Intramedullary nailing of the fractured tibial shaft.
Partial-weight bearing
Partial weight-bearing for the first 6 weeks postoperatively.
Partial weight-bearing
Instruction for partial weight-bearing for 6 weeks postoperatively
Intramedullary nailing
Intramedullary nailing of the fractured tibial shaft.
Interventions
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Full weight-bearing
Instruction for full and immediate weight-bearing postoperatively
Partial weight-bearing
Instruction for partial weight-bearing for 6 weeks postoperatively
Intramedullary nailing
Intramedullary nailing of the fractured tibial shaft.
Eligibility Criteria
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Inclusion Criteria
* operated within 72 hours of admittance
* age between 18-65 years
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Tampere University Hospital
OTHER
Responsible Party
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Aleksi Reito
Associate professor
Principal Investigators
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Aleksi Reito, Assoc prof
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
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Central Finland Hospital Nova
Jyväskylä, Central Finland, Finland
Tampere Univeristy Hospital
Tampere, Pirkanmaa, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R21010
Identifier Type: -
Identifier Source: org_study_id
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