NCT01015924

Brief Summary

The purpose of this study is to compare two widely used operative techniques on displaced midshaft clavicular fractures. The hypothesis is that there is no difference in functional outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

4.2 years

First QC Date

November 17, 2009

Last Update Submit

January 30, 2014

Conditions

Clavicle Fractures

Keywords

clavicleTENPlate osteosynthesisdisplacedESINdisplaced midshaft clavicular fractures

Outcome Measures

Primary Outcomes (1)

  • Functional outcome using DASH score

    quick dash w 1 thru 6. DASH at 6, 12, 26, 52

Secondary Outcomes (3)

  • At each control, complication such as infection, thoracic outlet syndrome is evaluated

    continuously, as well as w 6, 12, 26, 52

  • Constant score

    evaluated 6w, 12w, 26w 52 w

  • SF 36

    26 w and 52 w

Study Arms (2)

Elastic Stable Intramedullary Nailing

ACTIVE COMPARATOR

Operative intervention with closed or open reduction and intramedullary stabilization of midshaft clavicle fractures

Procedure: plate osteosynthesisProcedure: ESIN

Plate osteosynthesis

ACTIVE COMPARATOR

Open reduction and plate fixation of midshaft clavicle fractures

Procedure: plate osteosynthesisProcedure: ESIN

Interventions

plate osteosynthesisPROCEDURE

Patients are operated upon within 3 w of the fracture

Also known as: The standard plate i a precontoured LCP clavicle plate by Synthes
Elastic Stable Intramedullary NailingPlate osteosynthesis
ESINPROCEDURE

Elastiv stable intramedullary nailing

Also known as: TEN, synthes
Elastic Stable Intramedullary NailingPlate osteosynthesis

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Dislplaced midshaft clavicular fractures with no cortical bone contact or shortening over 15 mm
  • Tenting/compromised skin
  • Axial malalignment over 30 degrees

You may not qualify if:

  • More than 4 weeks old fracture
  • Ipsilateral damage that will influence the recovery and scoring systems, ie. Rotator cuff injury/fracture
  • Pathological fracture
  • Neurovascular injury
  • Open fracture
  • Noncompliance
  • Congenital anomaly or bone disease
  • Ongoing infectious process around the incision site for plate osteosynthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Study Officials

  • Stein Erik Utvag, MD PhD

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof. Stein Erik Utvåg, MD, PhD

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

NO(1)