NCT05151926

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Dec 2021Dec 2027

First Submitted

Initial submission to the registry

October 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

5.1 years

First QC Date

October 22, 2021

Last Update Submit

December 31, 2024

Conditions

Tibia Fracture

Keywords

intramedullary nailweight-bearing

Outcome Measures

Primary Outcomes (2)

  • Return to work

    Rate of return to work

    3 months

  • Physical component summary

    Physical component summary of the SF-36 questionnaire

    3 months

Secondary Outcomes (26)

  • Return to work

    6 months

  • Return to work

    12 months

  • Physical component summary

    6 months

  • Physical component summary

    12 months

  • Total sick leave

    12 months

  • +21 more secondary outcomes

Other Outcomes (1)

  • Total ground force during gait

    3 weeks

Study Arms (2)

Full weight-bearing

EXPERIMENTAL

Full immediate weight-bearing postoperatively

Procedure: Full weight-bearingProcedure: Intramedullary nailing

Partial-weight bearing

ACTIVE COMPARATOR

Partial weight-bearing for the first 6 weeks postoperatively.

Procedure: Partial weight-bearingProcedure: Intramedullary nailing

Interventions

Full weight-bearingPROCEDURE

Instruction for full and immediate weight-bearing postoperatively

Full weight-bearing
Partial weight-bearingPROCEDURE

Instruction for partial weight-bearing for 6 weeks postoperatively

Partial-weight bearing
Intramedullary nailingPROCEDURE

Intramedullary nailing of the fractured tibial shaft.

Full weight-bearingPartial-weight bearing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central Finland Hospital Nova

Jyväskylä, Central Finland, Finland

NOT YET RECRUITING

Tampere Univeristy Hospital

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Turku University Hospital

Turku, Southwest Finland, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Interventions

Partial Weight-BearingFracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Weight-BearingMechanical PhenomenaPhysical PhenomenaFracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Aleksi Reito, Assoc prof

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksi Reito, Assoc prof

CONTACT

+358444729631aleksi.reito@pshp.fi

Satu Ylä-Mononen

CONTACT

satu.yla-mononen@pshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

December 9, 2021

Study Start

December 3, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

IDP can be shared based on a reasonable request

Access Criteria
On a reasonable request along with a research plan.

Locations

FI(3)