NCT01234493

Brief Summary

The aim of our study was to determine whether transfixation of unstable syndesmosis is necessary in supination-external rotation type ankle fractures. Our hypothesis was that syndesmotic ligaments heal at the proper length after malleolar reduction and that syndesmotic transfixation is not needed in supination-external rotation fracture types.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

3.2 years

First QC Date

November 2, 2010

Last Update Submit

May 13, 2016

Conditions

Trauma

Keywords

ankle; fracture; syndesmosis;

Outcome Measures

Primary Outcomes (1)

  • Olerud-Molander score

    minimum one year

Study Arms (2)

fixation

ACTIVE COMPARATOR

Syndesmosis fixation with one 3.5mm fully threaded screw

Procedure: fixation

no fixation

ACTIVE COMPARATOR

No syndesmosis fixation

Procedure: no fixation

Interventions

fixationPROCEDURE

Syndesmosis fixation with one 3.5mm fully threaded three cortical screw

fixation
no fixationPROCEDURE

No syndesmosis fixation.

no fixation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All skeletally mature patients (≥16 years old) with a unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital

You may not qualify if:

  • Bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Oulu, 90650, Finland

Location

MeSH Terms

Conditions

Wounds and InjuriesFractures, Bone

Study Officials

  • Harri J Pakarinen, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 4, 2010

Study Start

June 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)