NCT01441817

Brief Summary

The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

6.3 years

First QC Date

September 15, 2011

Last Update Submit

September 27, 2011

Conditions

Ankle Malleolus Fracture BimalleolarFracture of Medial MalleolusFracture of Ankle

Outcome Measures

Primary Outcomes (2)

  • American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)

    Average of 42 months

  • The Olerud Molander Ankle score (OMAS)

    Average of 42 months

Secondary Outcomes (2)

  • Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)

    Average of 42 months

  • VAS score

    Average of 42 months

Study Arms (1)

Surgery

OTHER
Procedure: Internal fixation

Interventions

Internal fixationPROCEDURE

Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.

Surgery

Eligibility Criteria

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

You may qualify if:

  • Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).

You may not qualify if:

  • Patients with OTA type 43 distal tibia fractures.
  • Patients with soft tissue injuries involving the medial malleolus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture 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

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 28, 2011

Study Start

May 1, 2002

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

NO(1)