Clinical Trials Directory

Trials / Completed

CompletedNCT04473638

Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
All
Age
15 Years – 75 Years
Healthy volunteers
Not accepted

Summary

To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

Detailed description

Introduction: The diagnosis and treatment of ankle medial ligament lesions in malleolar fractures have always been surrounded by controversies. Even in the certainty of deltoid involvement and its consequent instability, the direct repair of this structure is not a consensus. In recent years, the arthroscopic technique to approach this ligament has been described with the objective of potentiating clinical results and minimizing possible complications. Objective: To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair. Methods: This is a retrospective study in patients diagnosed with ankle fractures associated with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic repair between January 2018 and January 2020. All patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up. Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. Additional studies, with a prospective and comparative methodology are required to sustain this proposal.

Conditions

Interventions

TypeNameDescription
PROCEDUREArthroscopic Deltoid Repair. A 4.5 mm arthroscopic set was used to clean the joint and assess medial and associated injuries. After deltoid injury confirmation through the method already mentioned, the medial gutter was prepared. The ideal positioning for the bone anchor in the medial malleolus followed Vega's recommendations and was located in the inferolateral quadrant created by the intersection of two lines: (1) tibia-talar joint line and (2) tangent line to the medial malleolus joint surface.(14). Sutures were passed respecting the safe zone illustrated by Acevedo at al, at the area between the posterior tibial tendon and the saphenous vein (16-25mm) (15). Sutures were passed but not tightened.

Timeline

Start date
2019-08-01
Primary completion
2020-11-01
Completion
2021-07-10
First posted
2020-07-16
Last updated
2021-07-19

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04473638. Inclusion in this directory is not an endorsement.