Treatment of Talus Fractures: a Retrospective Study (TTF2017)

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.

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.

Study Overview

• Status: Completed
• Conditions: Talus Fracture
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	at last follow-up (seven years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	at last follow-up (seven years)

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Carlo Biz, MD, Padua University Orthopaedic Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 31, 2012
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: talar fractures; talar neck fractures;; talar body fractures;; talus;; ORIF;; screw fixation.
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 4065/AO/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No