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NCT Number: NCT05151926

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

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.

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Key information

Conditions

Tibia Fracture Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Hospital Nova, Jyväskylä, Central Finland, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full weight-bearing

Procedure

Instruction for full and immediate weight-bearing postoperatively

Partial weight-bearing

Procedure

Instruction for partial weight-bearing for 6 weeks postoperatively

intramedullary nailing

Procedure

Intramedullary nailing of the fractured tibial shaft.

Primary outcomes

  1. Return to work

    Time frame: 3 months

    Rate of return to work

  2. Physical component summary

    Time frame: 3 months

    Physical component summary of the SF-36 questionnaire

Secondary outcomes

  1. Return to work

    Time frame: 6 months

    Rate of return to work

  2. Return to work

    Time frame: 12 months

    Rate of return to work

  3. Physical component summary

    Time frame: 6 months

    Physical component summary of the SF-36 questionnaire

  4. Physical component summary

    Time frame: 12 months

    Physical component summary of the SF-36 questionnaire

  5. Total sick leave

    Time frame: 12 months

    Overall length of sick leave

  6. Lower extremity functional scale

    Time frame: 3 months

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

  7. Lower extremity functional scale

    Time frame: 6 months

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

  8. Lower extremity functional scale

    Time frame: 12 months

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

  9. Lower extremity functional scale

    Time frame: 24 months

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

  10. 36-Item Short Form Survey

    Time frame: 3 months

  11. 36-Item Short Form Survey

    Time frame: 6 months

  12. 36-Item Short Form Survey

    Time frame: 12 months

  13. 36-Item Short Form Survey

    Time frame: 24 months

  14. Tegner activity level scale

    Time frame: 3 months

    Method of grading work and sporting activities

  15. Tegner activity level scale

    Time frame: 6 months

    Method of grading work and sporting activities

  16. Tegner activity level scale

    Time frame: 12 months

    Method of grading work and sporting activities

  17. Tegner activity level scale

    Time frame: 24 months

  18. University of California and Los Angeles activity level scale

    Time frame: 3 months

    Method of grading work and sporting activities

  19. University of California and Los Angeles activity level scale

    Time frame: 6 months

    Method of grading work and sporting activities

  20. University of California and Los Angeles activity level scale

    Time frame: 12 months

    Method of grading work and sporting activities

  21. University of California and Los Angeles activity level scale

    Time frame: 24 months

    Method of grading work and sporting activities

  22. Complications

    Time frame: 6 weeks

    Surgery related complications

  23. Complications

    Time frame: 3 months

    Surgery related complications

  24. Complications

    Time frame: 6 months

    Surgery related complications

  25. Complications

    Time frame: 12 months

    Surgery related complications

  26. Complications

    Time frame: 24 months

    Surgery related complications

Other outcomes

  1. Total ground force during gait

    Time frame: 3 weeks

    Measurement of lower leg activity using pressure insoles

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksi Reito, Assoc prof

CONTACT

[email protected]

+358444729631

Satu Ylä-Mononen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study 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

Acronym: LIMPER-TSF

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2021
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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