TTF2017: Treatment of Talus Fractures: a Retrospective Study

Sponsor

University of Padova (Other)

Overall Status

Completed

CT.gov ID

NCT03639272

Collaborator

(none)

Enrollment

133.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Talus Fracture	Procedure: open reduction and internal fixation (ORIF).

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.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 31, 2012

Actual Study Completion Date :

Feb 28, 2018

Outcome Measures

Primary Outcome Measures

Evaluation of the quality reduction after surgery [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 [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.
Evaluation of osteonecrosis [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 development of post-injury peritalar osteoarthritis [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 Outcome Measures

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score [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.
the Maryland Foot Score (MFS) [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.
the 17-Foot Functional Index (FFI-17) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.