Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF)

Tampere University Hospital

Status: Enrolling

Conditions: Tibia Fracture

Treatments: Procedure: Intramedullary nailing; Procedure: Full weight-bearing; Procedure: Partial weight-bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT05151926

R21010

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Full weight-bearing

Experimental group

Description:

Full immediate weight-bearing postoperatively

Treatment:

Procedure: Full weight-bearing

Procedure: Intramedullary nailing

Partial-weight bearing

Active Comparator group

Description:

Partial weight-bearing for the first 6 weeks postoperatively.

Treatment:

Procedure: Partial weight-bearing

Procedure: Intramedullary nailing