Skip to main content
OpenTrials
Completed

NCT Number: NCT04459910

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal University of Sao Paulo

São Paulo, 04022-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 6th post-operataive month

    Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)

  2. Complications

    Time frame: 6th post-operataive month

    Surgical complications

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.