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Completed

NCT Number: NCT01316289

Pilon Fracture Reduction and Functional Outcome

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.

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Key information

Conditions

Pilon Fracture of Tibia Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 2 years

    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 outcomes

  1. Surgical details

    Time frame: 1 year

    • 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)

  2. Pre- and postoperative treatment

    Time frame: 1 year

    Perioperative management data will include documentation of the use of thromboprophylaxis or prophylactic antibiotics, therapeutic antibiotics and pain medication including nonsteroidal antiinflammatory drugs (NSAID).

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

    Time frame: 1 year

    Trauma expectations factor (TEF) to assess the patient and surgeon expectations about the outcome of the treatment

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2011
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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