Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series

February 2, 2021 updated by: Nacime Salomão Barbachan Mansur, Federal University of São Paulo

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

Study Overview

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Sao Paulo, SP, Brazil, 04022-001
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary teaching hospital patients, athletes and non-athletes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multidirectional
Arthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair.
After anesthesia and surgical site preparation, traditional arthroscopic portals were performed. A 4.5mm set was used to clean the joint and assess possible associated injuries. Anterolateral and anteromedial impacts were resected when needed. Lateral and medial instability were confirmed arthroscopically, and ligament repairs prepared, starting by the lateral compartment. A traditional Arthroscopic Brostrom was performed, using one anchor and suture passers. Sutures are passed but not tightened. Medial anchor insertion is executed at the medial malleolus, in the quadrant described by Vega et al. Sutures were passed respecting the safe zone illustrated by Acevedo at al. The ankle was positioned in neutral (no posterior drawer) and the lateral sutures tightened with arthroscopic knots. Finally, the medial repair is finalized by tightening the deltoid sutures with the ankle at the same position. Portals were closed and a dressing applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
Time Frame: 6th post-operataive month
Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)
6th post-operataive month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 6th post-operataive month
Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)
6th post-operataive month
Complications
Time Frame: 6th post-operataive month
Surgical complications
6th post-operataive month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nacime Salomão Barbachan Mansur, MD, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the ICMJE data sharing police, core records will be shared at an online depository and available upon request.

IPD Sharing Time Frame

After the article is published.

IPD Sharing Access Criteria

A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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