Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Tibia Fracture Clinical Trial

— LIMPER-TSF  

Official title:

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF): a Protocol for Prospective, Randomized,Multicentre Trial Comparing the Early Partial and Early Full Weightbearing After Nailed Tibial Shaft Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151926
• Other study ID #: R21010
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2022
• Source: Tampere University Hospital
• Contact: Aleksi Reito, Assoc prof
• Phone: +358444729631
• Email: aleksi.reito[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Tibia Fracture
• Tibial Fractures

Intervention

Procedure:
• Full weight-bearing
Instruction for full and immediate weight-bearing postoperatively
• Partial weight-bearing
Instruction for partial weight-bearing for 6 weeks postoperatively
• Intramedullary nailing
Intramedullary nailing of the fractured tibial shaft.

Locations

Country	Name	City	State
Finland	Central Finland Hospital Nova	Jyväskylä	Keski-Suomi
Finland	Tampere Univeristy Hospital	Tampere	Pirkanmaa
Finland	Turku University Hospital	Turku	Varsinais-Suomi

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total ground force during gait	Measurement of lower leg activity using pressure insoles	3 weeks
Primary	Return to work	Rate of return to work	3 months
Primary	Physical component summary	Physical component summary of the SF-36 questionnaire	3 months
Secondary	Return to work	Rate of return to work	6 months
Secondary	Return to work	Rate of return to work	12 months
Secondary	Physical component summary	Physical component summary of the SF-36 questionnaire	6 months
Secondary	Physical component summary	Physical component summary of the SF-36 questionnaire	12 months
Secondary	Total sick leave	Overall length of sick leave	12 months
Secondary	Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	3 months
Secondary	Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	6 months
Secondary	Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	12 months
Secondary	Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	24 months
Secondary	36-Item Short Form Survey		3 months
Secondary	36-Item Short Form Survey		6 months
Secondary	36-Item Short Form Survey		12 months
Secondary	36-Item Short Form Survey		24 months
Secondary	Tegner activity level scale	Method of grading work and sporting activities	3 months
Secondary	Tegner activity level scale	Method of grading work and sporting activities	6 months
Secondary	Tegner activity level scale	Method of grading work and sporting activities	12 months
Secondary	Tegner activity level scale		24 months
Secondary	University of California and Los Angeles activity level scale	Method of grading work and sporting activities	3 months
Secondary	University of California and Los Angeles activity level scale	Method of grading work and sporting activities	6 months
Secondary	University of California and Los Angeles activity level scale	Method of grading work and sporting activities	12 months
Secondary	University of California and Los Angeles activity level scale	Method of grading work and sporting activities	24 months
Secondary	Complications	Surgery related complications	6 weeks
Secondary	Complications	Surgery related complications	3 months
Secondary	Complications	Surgery related complications	6 months
Secondary	Complications	Surgery related complications	12 months
Secondary	Complications	Surgery related complications	24 months