Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pilon Fracture Reduction and Functional Outcome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01316289
First received: March 14, 2011
Last updated: February 12, 2016
Last verified: February 2016
  Purpose

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.


Condition
Pilon Fracture of Tibia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Surgical details [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Length of surgery (skin-to-skin time)
    • Type of implant used
    • Use of bone graft
    • Soft tissue or wound-related procedures (eg, debridement, free flap, local flap, split skin graft)

  • Pre- and postoperative treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Perioperative management data will include documentation of the use of thromboprophylaxis or prophylactic antibiotics, therapeutic antibiotics and pain medication including nonsteroidal antiinflammatory drugs (NSAID).

  • To assess whether patient and surgeon expectations are met with regard to the trauma outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Trauma expectations factor (TEF) to assess the patient and surgeon expectations about the outcome of the treatment


Enrollment: 117
Study Start Date: November 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed Description:
A prospective case series to 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. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pilon fractures that fulfill the following inclusion and exclusion criteria
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316289

Locations
United States, Indiana
Indiana Orthopaedic Hospital
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
St. Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
Brazil
Universidade de São Paulo - Faculdade de Medicina
Cerqueira Cesar - Sao Paulo, CEP, Brazil, 05403-010
Switzerland
Cantonal Hospital Graubuenden
Chur, Switzerland, 7000
Cantonal Hospital Luzern
Luzern, Switzerland, 6000
Cantonal Hospital Winterthur
Winterthur, Switzerland, 8401
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Christoph Sommer, MD Cantonal Hospital Graubuenden
Study Director: Andreas Faeh AO Clinical Investigation and Documentation, Davos, Switzerland
  More Information

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01316289     History of Changes
Other Study ID Numbers: Pilon 
Study First Received: March 14, 2011
Last Updated: February 12, 2016
Health Authority: Austria: Ethikkommission
Brazil: Ethics Committee
Germany: Ethics Commission
Switzerland: Ethikkommission
United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation:
tibial fractures
pilon
pilon fractures
tibial plafond
reduction quality
anatomical reduction
functional outcome
ankle joint

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on December 09, 2016