Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (NCT05151926) | Clinical Trial Compass
RecruitingNot Applicable
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
Finland240 participantsStarted 2021-12-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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