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Tibia FractureLIMPER-TSFNCT05151926

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

A study testing Full weight-bearing, Partial weight-bearing and Intramedullary nailing in people with Tibia Fracture, run by Tampere University Hospital at 3 sites in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tibia Fracture
What is being tested?
Full weight-bearing, Partial weight-bearing and Intramedullary nailing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
3 sitesFinland
Study dates
3 Dec 2021to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aleksi Reito, Assoc prof contact

+358444729631

aleksi.reito@pshp.fi

Satu Ylä-Mononen contact

satu.yla-mononen@pshp.fi

Finland3 sites, 3 recruiting

  • Central Finland Hospital Nova

    Jyväskylä, Central Finland

    Ville Ponkilainen, Assoc prof, ville.ponkilainen@ksshp.fi

    Not yet recruiting

  • Tampere Univeristy Hospital

    Tampere, Pirkanmaa, 33520

    Aleksi Reito, Assoc prof, aleksi.reito@pshp.fi

    Recruiting

  • Turku University Hospital

    Turku, Southwest Finland

    Elina Ekman, MD, PhD, elina.ekman@tyks.fi

    Not yet recruiting

Other trials in Finland

About this study

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

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.

Conditions
Tibia Fracture
Being tested
Full weight-bearing, Partial weight-bearing, Intramedullary nailing
Keywords
intramedullary nail, weight-bearing
Medical subject headings
Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full weight-bearingProcedure or surgery

    Instruction for full and immediate weight-bearing postoperatively

  • Partial weight-bearingProcedure or surgery

    Instruction for partial weight-bearing for 6 weeks postoperatively

  • Intramedullary nailingProcedure or surgery

    Intramedullary nailing of the fractured tibial shaft.

Study groups in NCT05151926
Study groupRoleWhat they receive
Full weight-bearingExperimentalFull immediate weight-bearing postoperatively
Receives: Procedure: Full weight-bearing; Procedure: Intramedullary nailing
Partial-weight bearingActive comparatorPartial weight-bearing for the first 6 weeks postoperatively.
Receives: Procedure: Partial weight-bearing; Procedure: Intramedullary nailing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return to work

    Rate of return to work

    Measured: 3 months

  2. Physical component summary

    Physical component summary of the SF-36 questionnaire

    Measured: 3 months

Secondary outcomes (26)

  1. Return to work

    Rate of return to work

    Measured: 6 months

  2. Return to work

    Rate of return to work

    Measured: 12 months

  3. Physical component summary

    Physical component summary of the SF-36 questionnaire

    Measured: 6 months

  4. Physical component summary

    Physical component summary of the SF-36 questionnaire

    Measured: 12 months

  5. Total sick leave

    Overall length of sick leave

    Measured: 12 months

  6. Lower extremity functional scale

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

    Measured: 3 months

  7. Lower extremity functional scale

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

    Measured: 6 months

  8. Lower extremity functional scale

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

    Measured: 12 months

  9. Lower extremity functional scale

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

    Measured: 24 months

  10. 36-Item Short Form Survey

    Measured: 3 months

  11. 36-Item Short Form Survey

    Measured: 6 months

  12. 36-Item Short Form Survey

    Measured: 12 months

  13. 36-Item Short Form Survey

    Measured: 24 months

  14. Tegner activity level scale

    Method of grading work and sporting activities

    Measured: 3 months

  15. Tegner activity level scale

    Method of grading work and sporting activities

    Measured: 6 months

  16. Tegner activity level scale

    Method of grading work and sporting activities

    Measured: 12 months

  17. Tegner activity level scale

    Measured: 24 months

  18. University of California and Los Angeles activity level scale

    Method of grading work and sporting activities

    Measured: 3 months

  19. University of California and Los Angeles activity level scale

    Method of grading work and sporting activities

    Measured: 6 months

  20. University of California and Los Angeles activity level scale

    Method of grading work and sporting activities

    Measured: 12 months

  21. University of California and Los Angeles activity level scale

    Method of grading work and sporting activities

    Measured: 24 months

  22. Complications

    Surgery related complications

    Measured: 6 weeks

  23. Complications

    Surgery related complications

    Measured: 3 months

  24. Complications

    Surgery related complications

    Measured: 6 months

  25. Complications

    Surgery related complications

    Measured: 12 months

  26. Complications

    Surgery related complications

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start3 Dec 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled clinical trial
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151926
Sponsor's protocol ID
R21010
Acronym
LIMPER-TSF
Status last verified
Dec 2024
First submitted
22 Oct 2021
Last updated
1 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IDP can be shared based on a reasonable request

Questions about this trial

What is this clinical trial studying?

A study testing Full weight-bearing, Partial weight-bearing and Intramedullary nailing in people with Tibia Fracture, run by Tampere University Hospital at 3 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleksi Reito, Assoc prof (+358444729631, aleksi.reito@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to work (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.

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