MedTrace Logo

Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures

NCT05501496 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-08-22

No results posted yet for this study

Summary

Tibial shaft fracture is a common fracture in the pediatric and adolescent population. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment.

The investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis.

Conditions

  • Fracture of Tibia

Interventions

PROCEDURE

intramedullary nailing

Flexible intramedullary nailing using 2 nails

PROCEDURE

casting

casting with long leg cast

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Ilkka Helenius, professor · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2032-12-31
Completion
2035-12-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501496 on ClinicalTrials.gov