Treatment of Talus Fractures: a Retrospective Study

NCT03639272 | Completed DMC

• 1 other identifier: 4065/AO/17
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Talus Fracture

Keywords

talar fractures; talar neck fractures;; talar body fractures;; talus;; ORIF;; screw fixation.

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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)

Interventions

open reduction and internal fixation (ORIF). PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Carlo Biz, MD

  Padua University Orthopaedic Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon, Assistant Professor

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 21, 2018
• Study Start: January 1, 2007
• Primary Completion: December 31, 2012
• Study Completion: February 28, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share