Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

N/ARecruitingNCT05151926

Tampere University Hospital240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Tibia Fracture

Interventions

Full weight-bearingPROCEDURE

Instruction for full and immediate weight-bearing postoperatively

Partial weight-bearingPROCEDURE

Instruction for partial weight-bearing for 6 weeks postoperatively

Intramedullary nailingPROCEDURE

Intramedullary nailing of the fractured tibial shaft.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Central Finland Hospital Nova

Jyväskylä, Central Finland, Finland

NOT_YET_RECRUITING

Tampere Univeristy Hospital

Tampere, Pirkanmaa, Finland

RECRUITING

Turku University Hospital

Turku, Southwest Finland, Finland

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Return to work

Rate of return to work

Time frame: 3 months

Physical component summary

Physical component summary of the SF-36 questionnaire

Time frame: 3 months

Secondary Outcomes

Return to work

Rate of return to work

Time frame: 6 months

Return to work

Rate of return to work

Time frame: 12 months

Physical component summary

Physical component summary of the SF-36 questionnaire

Time frame: 6 months

Physical component summary

Physical component summary of the SF-36 questionnaire

Time frame: 12 months

Total sick leave

Overall length of sick leave

Time frame: 12 months

Lower extremity functional scale

Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).

Time frame: 3 months

Lower extremity functional scale

Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).

Time frame: 6 months

Central Contacts

Aleksi Reito, Assoc prof

CONTACT

+358444729631 aleksi.reito@pshp.fi

Satu Ylä-Mononen

CONTACT

satu.yla-mononen@pshp.fi

Data from ClinicalTrials.gov

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