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RecruitingNot ApplicableNCT05151926

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

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

Sponsor

Tampere University Hospital

Enrollment

240 participants

Start Date

Dec 3, 2021

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria16

  • 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

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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.

Locations(3)

Central Finland Hospital Nova

Jyväskylä, Central Finland, Finland

Tampere Univeristy Hospital

Tampere, Pirkanmaa, Finland

Turku University Hospital

Turku, Southwest Finland, Finland

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NCT05151926