Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF)
Primary Purpose
Tibia Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Full weight-bearing
Partial weight-bearing
Intramedullary nailing
Sponsored by
About this trial
This is an interventional treatment trial for Tibia Fracture focused on measuring intramedullary nail, weight-bearing
Eligibility Criteria
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
Sites / Locations
- Central Finland Hospital Nova
- Tampere Univeristy HospitalRecruiting
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Full weight-bearing
Partial-weight bearing
Arm Description
Full immediate weight-bearing postoperatively
Partial weight-bearing for the first 6 weeks postoperatively.
Outcomes
Primary Outcome Measures
Return to work
Rate of return to work
Physical component summary
Physical component summary of the SF-36 questionnaire
Secondary Outcome Measures
Return to work
Rate of return to work
Return to work
Rate of return to work
Physical component summary
Physical component summary of the SF-36 questionnaire
Physical component summary
Physical component summary of the SF-36 questionnaire
Total sick leave
Overall length of sick leave
Lower extremity functional scale
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Lower extremity functional scale
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Lower extremity functional scale
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Lower extremity functional scale
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
36-Item Short Form Survey
36-Item Short Form Survey
36-Item Short Form Survey
36-Item Short Form Survey
Tegner activity level scale
Method of grading work and sporting activities
Tegner activity level scale
Method of grading work and sporting activities
Tegner activity level scale
Method of grading work and sporting activities
Tegner activity level scale
University of California and Los Angeles activity level scale
Method of grading work and sporting activities
University of California and Los Angeles activity level scale
Method of grading work and sporting activities
University of California and Los Angeles activity level scale
Method of grading work and sporting activities
University of California and Los Angeles activity level scale
Method of grading work and sporting activities
Complications
Surgery related complications
Complications
Surgery related complications
Complications
Surgery related complications
Complications
Surgery related complications
Complications
Surgery related complications
Full Information
NCT ID
NCT05151926
First Posted
October 22, 2021
Last Updated
October 21, 2022
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05151926
Brief Title
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
Acronym
LIMPER-TSF
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibia Fracture
Keywords
intramedullary nail, weight-bearing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Full weight-bearing
Arm Type
Experimental
Arm Description
Full immediate weight-bearing postoperatively
Arm Title
Partial-weight bearing
Arm Type
Active Comparator
Arm Description
Partial weight-bearing for the first 6 weeks postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Full weight-bearing
Intervention Description
Instruction for full and immediate weight-bearing postoperatively
Intervention Type
Procedure
Intervention Name(s)
Partial weight-bearing
Intervention Description
Instruction for partial weight-bearing for 6 weeks postoperatively
Intervention Type
Procedure
Intervention Name(s)
Intramedullary nailing
Intervention Description
Intramedullary nailing of the fractured tibial shaft.
Primary Outcome Measure Information:
Title
Return to work
Description
Rate of return to work
Time Frame
3 months
Title
Physical component summary
Description
Physical component summary of the SF-36 questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Return to work
Description
Rate of return to work
Time Frame
6 months
Title
Return to work
Description
Rate of return to work
Time Frame
12 months
Title
Physical component summary
Description
Physical component summary of the SF-36 questionnaire
Time Frame
6 months
Title
Physical component summary
Description
Physical component summary of the SF-36 questionnaire
Time Frame
12 months
Title
Total sick leave
Description
Overall length of sick leave
Time Frame
12 months
Title
Lower extremity functional scale
Description
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Time Frame
3 months
Title
Lower extremity functional scale
Description
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Time Frame
6 months
Title
Lower extremity functional scale
Description
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Time Frame
12 months
Title
Lower extremity functional scale
Description
Measurement of lower extremity function with a scale from 0 (worst) to 100 (best).
Time Frame
24 months
Title
36-Item Short Form Survey
Time Frame
3 months
Title
36-Item Short Form Survey
Time Frame
6 months
Title
36-Item Short Form Survey
Time Frame
12 months
Title
36-Item Short Form Survey
Time Frame
24 months
Title
Tegner activity level scale
Description
Method of grading work and sporting activities
Time Frame
3 months
Title
Tegner activity level scale
Description
Method of grading work and sporting activities
Time Frame
6 months
Title
Tegner activity level scale
Description
Method of grading work and sporting activities
Time Frame
12 months
Title
Tegner activity level scale
Time Frame
24 months
Title
University of California and Los Angeles activity level scale
Description
Method of grading work and sporting activities
Time Frame
3 months
Title
University of California and Los Angeles activity level scale
Description
Method of grading work and sporting activities
Time Frame
6 months
Title
University of California and Los Angeles activity level scale
Description
Method of grading work and sporting activities
Time Frame
12 months
Title
University of California and Los Angeles activity level scale
Description
Method of grading work and sporting activities
Time Frame
24 months
Title
Complications
Description
Surgery related complications
Time Frame
6 weeks
Title
Complications
Description
Surgery related complications
Time Frame
3 months
Title
Complications
Description
Surgery related complications
Time Frame
6 months
Title
Complications
Description
Surgery related complications
Time Frame
12 months
Title
Complications
Description
Surgery related complications
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Total ground force during gait
Description
Measurement of lower leg activity using pressure insoles
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksi Reito, Assoc prof
Phone
+358444729631
Email
aleksi.reito@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Satu Ylä-Mononen
Email
satu.yla-mononen@pshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, Assoc prof
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Hospital Nova
City
Jyväskylä
State/Province
Keski-Suomi
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ville Ponkilainen, Assoc prof
Email
ville.ponkilainen@ksshp.fi
Facility Name
Tampere Univeristy Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, Assoc prof
Email
aleksi.reito@pshp.fi
Facility Name
Turku University Hospital
City
Turku
State/Province
Varsinais-Suomi
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elina Ekman, MD, PhD
Email
elina.ekman@tyks.fi
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IDP can be shared based on a reasonable request
IPD Sharing Access Criteria
On a reasonable request along with a research plan.
Learn more about this trial
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture
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