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Completed

NCT Number: NCT03639272

Treatment of Talus Fractures: a Retrospective Study

The main purpose of this retrospective case series study was to evaluate long-term radiographic and clinical outcomes of a consecutive series of patients with diagnosis of isolated, displaced, closed talar neck or body fractures treated by open reduction and internal fixation. Secondly, it was aimed to verify the influence of the location of talar fractures on the outcomes, the prognostic value of the Hawkins sign, whether operative delays promote avascular necrosis (AVN) and if the fractures require emergent surgical management.

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Key information

Conditions

Talus Fracture

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

From January 2007 to December 2012, 31 patients underwent ORIF by screws at our institution. On the basis of Inokuchi criteria, the injuries were divided between neck and body fractures, which were classified according to Hawkins and Sneppen, respectively. The patients included were divided into two groups in relation to fracture location and complexity. Radiographic assessment focused on reduction quality, bone healing, Hawkins sign and osteoarthritis development. For clinical evaluation, clinical-functional scores (AOFAS Ankle-Hindfoot Score; MFS; FFI-17; SF-36) and VAS were determined, and statistical analysis was performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of a closed, isolated, displaced talar neck or body fracture with 2 or more millimetres displacement, subsequently treated by ORIF
  • age between 18 and 85 years
  • informed consent to participate.

Exclusion criteria

  • undisplaced fractures or involvement of both the neck and the body,
  • open fractures, talar head and peripheral fractures including posterior process, osteochondral fractures, primary arthrodesis or amputation,
  • history of severe neurological deficit,
  • previous foot surgery or trauma,
  • diagnosis of rheumathological diseases or psoriatic arthritis, foot neuropathy, severe vascular insufficiency and alcohol or drug abuse.

Treatment and study plan

open reduction and internal fixation (ORIF).

Procedure

Depending on the fracture location, a single anteromedial or anterolateral approach was carried out. The fracture site was cleaned to make it visible, allowing anatomical reduction. Subsequently, fixation of provisional fragments was achieved using temporary Kirschner wires under radiographic guidance. Having obtained satisfactory reduction as seen with the radiographic intensifier, definitive fixation of the main bone fragments was carried out using two or more 3.5 mm titanium cannulated screws or 4.0 mm lag screws, placed anteriorly to posteriorly. Fractures complicated by severe comminution necessitated 3.5 mm cortical screws in order to avoid shortening, translation or angulation of the fragments.

Other names: ORIF

Primary outcomes

  1. Evaluation of the quality reduction after surgery

    Time frame: at day 1 after surgery

    Radiographic examination of anteroposterior, lateral and oblique view radiographs enabled to evaluate the quality of the reduction. Any offset of more than 2 mm or neck angulation of more than 5° between the fragment was labelled as a poor reduction.

  2. Evaluation of bone healing

    Time frame: at different follow-ups (1 month, 3 months, 6 months, 12 months, 24 months)

    Criteria to define bone healing and union:

    The bridging bone/callus formation was evaluated on radiographs The absence of radiolucent lines was verified at different follow-ups.

  3. Evaluation of osteonecrosis

    Time frame: at 6-8 weeks after injury

    The Hawkins sign appearance (only on the A/P X-ray), which resembles a subchondral atrophy in the talus dome, was evaluated indicating that the talus is well vascularized. On the contrary, its absence at this time suggests the presence of osteonecrosis

  4. Evaluation of the development of post-injury peritalar osteoarthritis

    Time frame: at last follow-up (seven years)

    Post-injury peritalar osteoarthritis was evaluated on X-ray and differentiated between necrosis without collapse (sclerosis with and without geodes) and necrosis with collapse of the talar dome at the last follow-up

Secondary outcomes

  1. American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score

    Time frame: at last follow-up (seven years)

    The AOFAS score enabled to quantify pain and functional disability. It includes 9 questions related to pain (1 question; 40 points), function (7 questions; 50 points) and alignment (10 questions; 10 points); a score of 90-100 is considered an excellent result; 75-89 as good; 50-74 as fair and less than 49 points is considered a failure or a poor outcome.

  2. the Maryland Foot Score (MFS)

    Time frame: at last follow-up (seven years)

    The MFS is a score conceptually analogous to AOFAS score, but points are differently distributed (45 for pain, 55 for functional limitation); they indicate excellent results if the score is between 90 to 100, good for a score of 75 to 89, fair for a score of 50 to 74 and poor if the score is < 50.

  3. the 17-Foot Functional Index (FFI-17)

    Time frame: at last follow-up (seven years)

    The FFI-17 measures the persistence of pain, disability and restriction of activity, with 17 number-rating scales from 0 to 10. The maximum score is 100, which indicates complete disability.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Long-term Radiographic and Clinical-functional Outcomes of Isolated, Displaced, Closed Talar Neck and Body Fractures Treated by Open Reduction Iternal Fixation: the Timing of Surgical Management.

Acronym: TTF2017

Important dates

Study start
2007
Primary completion
2012
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Aug 21, 2018

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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