Clinical trial NCT04473638: Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series
Official title: Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Ankle Fractures
Deltoid Ligament; Sprain (Strain) (Ankle)
Ligament Rupture
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary/Quaternary hospital patients

Brief 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.

Eligibility criteria: Inclusion Criteria:

- acute (less than two weeks) ankle fracture containing a medial ligament injury suspicion will be included. Syndesmotic lesion with a deltoid association will also be addressed

Exclusion Criteria:

* previous surgery
* autoimmune diseases
* neuropathy
* inflammatory diseases
* radiographic preoperative findings of ankle arthritis
* open medial wound
* coagulopathies
* any other condition that would contraindicate surgery

Primary outcomes:
measure: American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
timeFrame: Time Frame: 6th post-operative month
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Time Frame: 6th post-operative month
measure: Number of Complications related to Treatment
timeFrame: 6th post-operative month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Nacime Salomão Barbachan Mansur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: