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Clinical Trials/NCT03639272
NCT03639272
Completed
Not Applicable

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.

University of Padova0 sites40 target enrollmentJanuary 1, 2007
ConditionsTalus Fracture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Talus Fracture
Sponsor
University of Padova
Enrollment
40
Primary Endpoint
Evaluation of the development of post-injury peritalar osteoarthritis
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2007
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Principal Investigator
Principal Investigator

Carlo Biz

Orthopedic surgeon, Assistant Professor

University of Padova

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.

Outcomes

Primary Outcomes

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

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

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.

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.

Secondary Outcomes

  • American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score(at last follow-up (seven years))
  • the Maryland Foot Score (MFS)(at last follow-up (seven years))
  • the 17-Foot Functional Index (FFI-17)(at last follow-up (seven years))

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