Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Not Applicable

Recruiting

• Conditions: Tibia Fracture
• Interventions: Procedure: Full weight-bearing; Procedure: Partial weight-bearing; Procedure: Intramedullary nailing

• Registration Number: NCT05151926
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-11-26
• Study Start: 2021-12-03
• Study First Posted: 2021-12-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full weight-bearing	Full weight-bearing	Full immediate weight-bearing postoperatively
Full weight-bearing	Intramedullary nailing	Full immediate weight-bearing postoperatively
Partial-weight bearing	Intramedullary nailing	Partial weight-bearing for the first 6 weeks postoperatively.
Partial-weight bearing	Partial weight-bearing	Partial weight-bearing for the first 6 weeks postoperatively.

Primary Outcome Measures

Name	Time	Method
Physical component summary	3 months	Physical component summary of the SF-36 questionnaire
Return to work	3 months	Rate of return to work

Secondary Outcome Measures

Name	Time	Method
Return to work	12 months	Rate of return to work
Physical component summary	12 months	Physical component summary of the SF-36 questionnaire
Total sick leave	12 months	Overall length of sick leave
Tegner activity level scale	24 months
Lower extremity functional scale	24 months	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
University of California and Los Angeles activity level scale	24 months	Method of grading work and sporting activities
Complications	24 months	Surgery related complications
36-Item Short Form Survey	24 months

Trial Locations

Locations (3)

Central Finland Hospital Nova; 🇫🇮 Jyväskylä, Keski-Suomi, Finland

Turku University Hospital; 🇫🇮 Turku, Varsinais-Suomi, Finland

Tampere Univeristy Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland