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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05151926
Other study ID # R21010
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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