An observational study in Talus Fracture, sponsored by University of Padova. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by University of Padova · Observational
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
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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)
Exclusion Criteria:
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.
Also known as: ORIF
Evaluation of the quality reduction 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.
Time frame: at day 1 after surgery
Evaluation of bone healing
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.
Time frame: at different follow-ups (1 month, 3 months, 6 months, 12 months, 24 months)
Evaluation of osteonecrosis
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
Time frame: at 6-8 weeks after injury
Evaluation of the development of post-injury peritalar osteoarthritis
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
Time frame: at last follow-up (seven years)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
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.
Time frame: at last follow-up (seven years)
the Maryland Foot Score (MFS)
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.
Time frame: at last follow-up (seven years)
the 17-Foot Functional Index (FFI-17)
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.
Time frame: at last follow-up (seven years)
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Plan to share: No
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University of Padova