Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF)

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.

Study Overview

• Status: Recruiting
• Conditions: Tibia Fracture
• Intervention / Treatment: Procedure: Full weight-bearing; Procedure: Intramedullary nailing; Procedure: Partial weight-bearing

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksi Reito, Assoc prof; Phone Number: +358444729631; Email: aleksi.reito@pshp.fi
• Study Contact Backup: Name: Satu Ylä-Mononen; Email: satu.yla-mononen@pshp.fi

Study Locations

• Finland
  • Keski-Suomi
    • Jyväskylä, Keski-Suomi, Finland
      • Not yet recruiting
      • Central Finland Hospital Nova
      • Contact: Ville Ponkilainen, Assoc prof; Email: ville.ponkilainen@ksshp.fi
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Recruiting
      • Tampere Univeristy Hospital
      • Contact: Aleksi Reito, Assoc prof; Email: aleksi.reito@pshp.fi
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland
      • Not yet recruiting
      • Turku University Hospital
      • Contact: Elina Ekman, MD, PhD; Email: elina.ekman@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full weight-bearing; Full immediate weight-bearing postoperatively	Procedure: Full weight-bearing; Instruction for full and immediate weight-bearing postoperatively; Procedure: Intramedullary nailing; Intramedullary nailing of the fractured tibial shaft.
Active Comparator: Partial-weight bearing; Partial weight-bearing for the first 6 weeks postoperatively.	Procedure: Intramedullary nailing; Intramedullary nailing of the fractured tibial shaft.; Procedure: Partial weight-bearing; Instruction for partial weight-bearing for 6 weeks postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work	Rate of return to work	3 months
Physical component summary	Physical component summary of the SF-36 questionnaire	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work	Rate of return to work	6 months
Return to work	Rate of return to work	12 months
Physical component summary	Physical component summary of the SF-36 questionnaire	6 months
Physical component summary	Physical component summary of the SF-36 questionnaire	12 months
Total sick leave	Overall length of sick leave	12 months
Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	3 months
Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	6 months
Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	12 months
Lower extremity functional scale	Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).	24 months
36-Item Short Form Survey		3 months
36-Item Short Form Survey		6 months
36-Item Short Form Survey		12 months
36-Item Short Form Survey		24 months
Tegner activity level scale	Method of grading work and sporting activities	3 months
Tegner activity level scale	Method of grading work and sporting activities	6 months
Tegner activity level scale	Method of grading work and sporting activities	12 months
Tegner activity level scale		24 months
University of California and Los Angeles activity level scale	Method of grading work and sporting activities	3 months
University of California and Los Angeles activity level scale	Method of grading work and sporting activities	6 months
University of California and Los Angeles activity level scale	Method of grading work and sporting activities	12 months
University of California and Los Angeles activity level scale	Method of grading work and sporting activities	24 months
Complications	Surgery related complications	6 weeks
Complications	Surgery related complications	3 months
Complications	Surgery related complications	6 months
Complications	Surgery related complications	12 months
Complications	Surgery related complications	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total ground force during gait	Measurement of lower leg activity using pressure insoles	3 weeks

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Aleksi Reito, Assoc prof, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: intramedullary nail; weight-bearing
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: R21010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IDP can be shared based on a reasonable request
• IPD Sharing Access Criteria: On a reasonable request along with a research plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No