Treatment of Talus Fractures: a Retrospective Study (TTF2017)
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|ClinicalTrials.gov Identifier: NCT03639272|
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Talus Fracture||Procedure: open reduction and internal fixation (ORIF).|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|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 :||January 1, 2007|
|Actual Primary Completion Date :||December 31, 2012|
|Actual Study Completion Date :||February 28, 2018|
- Procedure: 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.Other Name: ORIF
- Evaluation of the quality reduction after surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639272
|Principal Investigator:||Carlo Biz, MD||Padua University Orthopaedic Clinic|