Actively Recruiting
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture Comparing Early Partial and Early Full Weight-Bearing After Intramedullary Nailing
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
Researchers are comparing two approaches to weight-bearing after a tibial shaft fracture treated with intramedullary nailing: immediate full weight-bearing versus partial weight-bearing for 6 weeks. The study focuses on adults aged 18 to 65 who have had a specific type of tibia fracture treated within 72 hours. The main goals are to see how quickly participants return to work and how their physical health is affected, as measured by the SF-36 questionnaire. Participants will receive intramedullary nailing surgery for their tibial shaft fracture. After surgery, they will be instructed to either bear full weight immediately or bear partial weight for six weeks. These two post-operative weight-bearing strategies will be compared to understand their impact on recovery. During the study, participants will be monitored for their ability to return to work and their physical health status at three months after the fracture. Questionnaires will assess physical function, and other clinical data will be collected to evaluate recovery. The study includes careful follow-up to measure outcomes related to rehabilitation and daily activities.
CONDITIONS
Official Title
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
Who Can Participate
Eligibility Criteria
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
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
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
Research Team
A
Aleksi Reito, Assoc prof
S
Satu Ylä-Mononen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here