Health TrialsbyHealthPanel

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

ConditionTibia Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTampere University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Full weight-bearing

    Procedure/Surgery

    Instruction for full and immediate weight-bearing postoperatively

  • Partial weight-bearing

    Procedure/Surgery

    Instruction for partial weight-bearing for 6 weeks postoperatively

  • Intramedullary nailing

    Procedure/Surgery

    Intramedullary nailing of the fractured tibial shaft.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Full weight-bearingExperimental treatment 2 interventions
Group B: Partial-weight bearingActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Return to work

Rate of return to work

Time frame
3 months
2

Physical component summary

Physical component summary of the SF-36 questionnaire

Time frame
3 months

Secondary outcomes

1

Return to work

Rate of return to work

Time frame
6 months
2

Return to work

Rate of return to work

Time frame
12 months
3

Physical component summary

Physical component summary of the SF-36 questionnaire

Time frame
6 months
4

Physical component summary

Physical component summary of the SF-36 questionnaire

Time frame
12 months

Other outcomes

1

Total ground force during gait

Measurement of lower leg activity using pressure insoles

Time frame
3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University Hospital

Lead sponsor

Source ClinicalTrials.gov
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