NCT02064595

Brief Summary

The objective of this research is to prospectively evaluate a group of patients with shaft compound fracture of the tibia, treated with a biplanar external fixator or locked intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and postoperative complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Status
completed

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 Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

February 3, 2014

Last Update Submit

February 18, 2014

Conditions

Open tíbia Fracture

Keywords

Tibial fractures.Fracture fixation.External fixators.Intramedullary.Quality of life.

Outcome Measures

Primary Outcomes (1)

  • Bone healing

    bone formation in 3 cortical through the fracture in x ray

    One year

Secondary Outcomes (1)

  • Quality of life

    1 year

Other Outcomes (1)

  • Infection

    1 year

Study Arms (2)

Intramedullary nail

OTHER

Fractures treated with intramedullary reamed nail

Procedure: Intramedullary nail

External fixator

ACTIVE COMPARATOR

Tibial fractures treated with biplanar external fixation

Procedure: External fixator

Interventions

External fixatorPROCEDURE

Treatment with external fixation

External fixator
Intramedullary nailPROCEDURE

Fracture treated with intramedullary nail

Intramedullary nail

Eligibility Criteria

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

You may qualify if:

  • the investigators considered those with shaft compound fracture of the tibia (occurring two inches below the knee and two inches above the ankle), that per the classification Gustillo and Anderson were grades I, II, and IIIA, in patients with a mature skeleton.

You may not qualify if:

  • The presence of extensive skin lesions and soft tissue or arterial injury requiring surgical repair (Grades IIIB and C) in the initial care, other fractures with the exception of the fibula, or the presence of wounds with signs of infection in the period between the accident and definitive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tibial Fractures

Interventions

External FixatorsFracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation DevicesFracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Md

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 17, 2014

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02