Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05151926

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Led by Tampere University Hospital · Updated on 2025-01-01

240

Participants Needed

3

Research Sites

317 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 and 65 years
Not Eligible

You will not qualify if you...

  • Inability to fill out the Finnish versions of the questionnaires
  • Previous arthroplasty of the knee or ankle on the fractured limb
  • Previous ipsilateral below-knee fracture requiring surgical treatment or ankle arthrodesis
  • Inability to cooperate
  • Not living independently before fracture (institutionalized living)
  • Open fracture Gustilo grade 2 or higher
  • Pathologic or stress fracture
  • Multiple fractures requiring surgery in polytrauma patients
  • Severe medical conditions impairing daily activities (unable to climb three floors without help)
  • Body Mass Index over 40
  • High surgical risk due to severe medical conditions
  • Severe substance abuse
  • Patient is retired
  • Age less than 18 or more than 65
  • Fasciotomy required due to acute compartment syndrome during or after surgery
  • Inability to walk before fracture or daily need for walking aid such as crutches

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Central Finland Hospital Nova

Jyväskylä, Central Finland, Finland

Not Yet Recruiting

2

Tampere Univeristy Hospital

Tampere, Pirkanmaa, Finland, 33520

Actively Recruiting

3

Turku University Hospital

Turku, Southwest Finland, Finland

Not Yet Recruiting

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Research Team

A

Aleksi Reito, Assoc prof

CONTACT

S

Satu Ylä-Mononen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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