Treatment of Talus Fractures: a Retrospective Study

NCT ID: NCT03639272

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Talus Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

open reduction and internal fixation (ORIF).

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ORIF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Padova

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carlo Biz

Orthopedic surgeon, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlo Biz, MD

Role: PRINCIPAL_INVESTIGATOR

Padua University Orthopaedic Clinic

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4065/AO/17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgery of the Pilon Fractures
NCT03367169 TERMINATED NA