Clinical trial NCT03639272: Treatment of Talus Fractures: a Retrospective Study
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Talus Fracture
Keywords: talar fractures
talar neck fractures;
talar body fractures;
talus;
ORIF;
screw fixation.
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 19 men (1 bilateral case for a total of 20 fractures, 71.4%) and 8 women (29.6%). Overall, mean age at the time of injury was 38.3 years old (range 18-81)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the quality reduction after surgery
timeFrame: at day 1 after surgery
measure: Evaluation of bone healing
timeFrame: at different follow-ups (1 month, 3 months, 6 months, 12 months, 24 months)
measure: Evaluation of osteonecrosis
timeFrame: at 6-8 weeks after injury
measure: Evaluation of the development of post-injury peritalar osteoarthritis
timeFrame: at last follow-up (seven years)
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
timeFrame: at last follow-up (seven years)
measure: the Maryland Foot Score (MFS)
timeFrame: at last follow-up (seven years)
measure: the 17-Foot Functional Index (FFI-17)
timeFrame: at last follow-up (seven years)
Other outcomes:
Locations:
Study officials:
affiliation: Padua University Orthopaedic Clinic
name: Carlo Biz, MD
role: PRINCIPAL_INVESTIGATOR
References: