Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Launched by TAMPERE UNIVERSITY HOSPITAL · Nov 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to manage weight-bearing after a tibial shaft fracture, which is a break in the long bone of the lower leg. The goal is to see whether patients do better when they are allowed to put full weight on their leg right away, compared to those who start with partial weight-bearing for the first six weeks after surgery. The researchers will look at how quickly participants can return to work and their overall physical health using a standard questionnaire.

To be eligible for this study, participants should be between 18 and 65 years old and have recently sustained a specific type of tibial fracture that was treated with a method called intramedullary nailing (a type of surgery where a rod is inserted into the bone). Those who have had previous major surgeries on the same leg, certain types of fractures, or other serious health issues may not qualify. Participants in the trial can expect regular check-ins and assessments related to their recovery, and their experiences will help improve treatment for future patients with similar injuries.

Gender

ALL

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