NCT01316289

Brief Summary

This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. The plates used in this trial can be chosen according to the preferences of the surgeon.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
4 countries

9 active sites

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

First Submitted

Initial submission to the registry

March 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 13, 2020

Status Verified

January 1, 2018

Enrollment Period

5.2 years

First QC Date

March 14, 2011

Last Update Submit

August 11, 2020

Conditions

Pilon Fracture of Tibia

Keywords

tibial fracturespilonpilon fracturestibial plafondreduction qualityanatomical reductionfunctional outcomeankle joint

Outcome Measures

Primary Outcomes (1)

  • Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation.

    The most important predictors of functional outcome after pilon fracture will be identified by evaluating the influence of radiologically assessed parameters of reduction quality and other factors (age, high/low energy trauma, AO fracture type, open/closed fracture, delay between trauma and definitive fracture fixation) on the FAAM. In parallel, the radiological parameters will also be validated with respect to their reliability.

    2 years

Secondary Outcomes (3)

  • Surgical details

    1 year

  • Pre- and postoperative treatment

    1 year

  • To assess whether patient and surgeon expectations are met with regard to the trauma outcome

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pilon fractures that fulfill the following inclusion and exclusion criteria

You may qualify if:

  • Age 18 years and older
  • Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)
  • Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)
  • Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations

You may not qualify if:

  • Contralateral fracture of the distal half of the tibia/fibula/talus
  • Pathologic fracture
  • Severe Polytrauma: Injury Severity Score (ISS) \> 28
  • Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)
  • Drug or alcohol abuse
  • American Society of Anesthesiologists (ASA) class V and VI
  • Inability to walk independently prior to injury event
  • Neurological and psychiatric disorders that would preclude reliable assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Indiana Orthopaedic Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Saint Paul, Minnesota, 55101, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Universidade de São Paulo - Faculdade de Medicina

São Paulo, CEP, 05403-010, Brazil

Location

Cantonal Hospital Graubuenden

Chur, 7000, Switzerland

Location

Cantonal Hospital Luzern

Lucerne, 6000, Switzerland

Location

Cantonal Hospital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Christoph Sommer, MD

    Cantonal Hospital Graubuenden

    PRINCIPAL INVESTIGATOR

  • Martin Schuler, PhD

    AO Clinical Investigation and Documentation, Davos, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 16, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

August 13, 2020

Record last verified: 2018-01

Locations

US(4)AU(1)CH(3)BR(1)