Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures

NCT05501496 | Not Yet Recruiting DMC

• 1 other identifier: ETMK105/1801/2017
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

conservative treatment; intramedullary nailing; pediatric tibial shaft fracture

Outcome Measures

Primary Outcomes (1)

• Malunion

  malunion described as coronal angulation over 5 degrees, sagittal angulation over 10 degrees, over 50% cortical overlap and over 1 cm shortening.

  one year

Secondary Outcomes (3)

• Pediatric Quality of Life Inventory

  one year

• number of reinterventions

  two year follow up period

• complication

  two year follow up

Study Arms (2)

Casting

OTHER

Displaced fracture will be treated with closed reduction and long leg cast under general anesthesia

Procedure: casting

intramedullary nailing

ACTIVE COMPARATOR

Displaced fracture will be treated with closed or open reduction and flexible intramedullary nailing

Procedure: intramedullary nailing

Interventions

intramedullary nailing PROCEDURE

Flexible intramedullary nailing using 2 nails

intramedullary nailing

casting PROCEDURE

casting with long leg cast

Casting

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 6 to 15-year old children with displaced tibial shaft fracture

You may not qualify if:

• Open fracture
• Compartment syndrome
• Neurovascular deficit
• Pathological fracture
• Systemic disease affecting bone structure and quality
• Associated injuries preventing either casting or intramedullary nailing.

Sponsors & Collaborators

• Turku University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator

Study Sites (2)

Juho-Antti Ahola

Helsinki, Finland

Location

Turku Children's Hospital

Turku, FI-20521, Finland

Location

Related Publications (1)

• Raducha JE, Swarup I, Schachne JM, Cruz AI Jr, Fabricant PD. Tibial Shaft Fractures in Children and Adolescents. JBJS Rev. 2019 Feb;7(2):e4. doi: 10.2106/JBJS.RVW.18.00047. No abstract available.

  PMID: 30817691 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Ilkka Helenius, professor

  Turku University Hospital

  STUDY DIRECTOR

Central Study Contacts

Juho-Antti Ahola, MD

CONTACT

+3584053464457; juho-antti.ahola@hus.fi

Ilkka Helenius, professor

CONTACT

+358504422881; ilkka.helenius@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)