Actively Recruiting
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF): Comparing Early Partial and Full Weightbearing After Nailed Tibial Shaft Fracture
Led by Tampere University Hospital · Updated on 2025-01-01
240
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different approaches to weight-bearing after a tibial shaft fracture treated with intramedullary nailing. The study compares immediate full weight-bearing with partial weight-bearing for the first six weeks following surgery. This trial aims to understand how these approaches affect recovery, focusing on return to work and physical health as measured by the SF-36 questionnaire. The research is led by Tampere University Hospital and involves adults aged 18 to 65 years. Participants receive intramedullary nailing to repair the tibial shaft fracture. After surgery, they are randomly assigned to either begin full weight-bearing immediately or to follow partial weight-bearing instructions for six weeks. These two groups enable comparison of early rehabilitation strategies to determine the best approach for recovery. Throughout the study, participants are monitored at multiple time points up to 24 months. Researchers assess return to work, physical health through the SF-36 physical component summary, and functional abilities using various scales such as the Lower Extremity Functional Scale and activity level scales. Complications and total sick leave are also tracked. The primary outcomes are evaluated at three months, with follow-up continuing up to two years to observe long-term recovery and function.
CONDITIONS
Brief 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
- Surgery performed within 72 hours of hospital admittance
- Age between 18 and 65 years
You will not qualify if you...
- Cannot complete Finnish versions of questionnaires
- Previous knee or ankle arthroplasty on fractured limb
- Previous ipsilateral below-knee fracture requiring surgery or ankle arthrodesis
- Inability to cooperate
- Not living independently before fracture
- Open fracture Gustilo grade 2 or higher
- Pathologic or stress fracture
- Multiple fractures needing surgery in polytrauma
- Severe medical conditions impairing daily activities
- Body Mass Index over 40
- High surgical risk due to severe medical conditions
- Severe substance abuse
- Retired patients
- Age under 18 or over 65
- Required fasciotomy due to compartment syndrome during or after surgery
- Unable to walk or needing daily walking aid before fracture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours from hospital admittance
Participants undergo intramedullary nailing of the fractured tibial shaft within 72 hours of hospital admittance.
1 visit (in-person)
Duration - 6 weeks
Participants receive either full immediate weight-bearing or partial weight-bearing for 6 weeks postoperatively following surgery.
Weekly visits for up to 6 weeks
Duration - Up to 24 months
Participants are monitored for recovery progress, return to work, physical function, and complications up to 24 months after treatment.
Scheduled visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months
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
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