NCT05151926 Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
| NCT ID | NCT05151926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Tibia Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-12-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2021-12-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Aleksi Reito, Assoc prof
PRINCIPAL INVESTIGATOR
Tampere University Hospital
Frequently Asked Questions
Who can join the NCT05151926 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Tibia Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05151926 currently recruiting?
Yes, NCT05151926 is actively recruiting participants. Contact the research team at aleksi.reito@pshp.fi for enrollment information.
Where is the NCT05151926 trial being conducted?
This trial is being conducted at Jyväskylä, Finland, Tampere, Finland, Turku, Finland.
Who is sponsoring the NCT05151926 clinical trial?
NCT05151926 is sponsored by Tampere University Hospital. The principal investigator is Aleksi Reito, Assoc prof at Tampere University Hospital. The trial plans to enroll 240 participants.