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New treatment option for Tibia Fracture
Official title Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
ClinicalTrials.gov ID: NCT05151926
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- AO/OTA 42-A/B acute, noncomminuted diaphyseal fracture of the tibia treated with intramedullary nailing with or without posterior malleolus screw...
- operated within 72 hours of admittance
- age between 18-65 years
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jyväskylä, Central Finland, Finland
- Tampere, Pirkanmaa, Finland
- Turku, Southwest Finland, Finland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jyväskylä, Central Finland, Finland; Tampere, Pirkanmaa, Finland; Turku, Southwest Finland, Finland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.