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Recruiting NCT05151926

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

No phase Interventional Tibia Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full weight-bearing, Partial weight-bearing, Intramedullary nailing.
Who it may be relevant to
Registry conditions: Tibia Fracture. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Full weight-bearing
    Instruction for full and immediate weight-bearing postoperatively
  • Procedure Partial weight-bearing
    Instruction for partial weight-bearing for 6 weeks postoperatively
  • Procedure Intramedullary nailing
    Intramedullary nailing of the fractured tibial shaft.

Primary outcome measures

  • Return to work [Time frame: 3 months]
  • Physical component summary [Time frame: 3 months]
Secondary outcome measures (12)
  • Return to work [Time frame: 6 months]
  • Return to work [Time frame: 12 months]
  • Physical component summary [Time frame: 6 months]
  • Physical component summary [Time frame: 12 months]
  • Total sick leave [Time frame: 12 months]
  • Lower extremity functional scale [Time frame: 3 months]
  • Lower extremity functional scale [Time frame: 6 months]
  • Lower extremity functional scale [Time frame: 12 months]
  • Lower extremity functional scale [Time frame: 24 months]
  • 36-Item Short Form Survey [Time frame: 3 months]
  • 36-Item Short Form Survey [Time frame: 6 months]
  • 36-Item Short Form Survey [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 3 centers
  • Central Finland Hospital Nova — Jyväskylä
  • Tampere Univeristy Hospital — Tampere
  • Turku University Hospital — Turku

Identifiers

NCT: NCT05151926 · R21010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗