Clinical trial NCT04459910: Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series
Official title: Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Ligament Injury
Joint Instability
Deltoid Ligament; Sprain (Strain) (Ankle)
Talofibular Ligament Tear
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 29
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
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 teaching hospital patients, athletes and non-athletes.

Brief summary: Abstract Introduction: The high prevalence of sprains in the population has provided a substantial number of patients with lateral instability of the ankle. The continuity of this condition can lead to the progressive loosening of the medial containment structures, generating a multidirectional rotational instability. The deltoid approach through the imbrication of its components has been proposed as a solution for these patients. The arthroscopic technique has been described as an alternative.

Methods: This is a retrospective study with patients diagnosed with multidirectional instability and submitted to an ankle arthroscopy with medial repair (arthroscopic tensioning) and lateral (arthroscopic Brostrom) 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 combined medial and lateral arthroscopic repair may be an effective and safe alternative in the treatment of multidirectional instability. 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.

Design: Level IV. Retrospective case series.

Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability


Eligibility criteria: Inclusion Criteria:

* complaints about ankle loosening for the last six months
* clinical findings of lateral and medial instability

Exclusion Criteria:

* existence of previous surgery
* autoimmune diseases
* neuropathy
* inflammatory disease
* isolated medial instability
* flatfoot
* previous ankle infiltration
* radiographic findings of ankle arthritis
* cavovarus deformity
* coagulopathies
* body mass index over 35
* associated injuries, such as osteochondral lesions
* syndesmosis instability
* tendon ruptures
* fractures

Primary outcomes:
measure: American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
timeFrame: 6th post-operataive month
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 6th post-operataive month
measure: Complications
timeFrame: 6th post-operataive 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: