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

NCT04459910 | Completed

• 1 other identifier: Multi_EPM
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Ankle Injuries; Ligament Injury; Joint Instability; Deltoid Ligament; Sprain (Strain) (Ankle); Talofibular Ligament Tear

Outcome Measures

Primary Outcomes (1)

• American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)

  Functional Score (0 to 100 \| 100 best score possible \| 0 worst score possible)

  6th post-operataive month

Secondary Outcomes (2)

• Visual Analogue Scale (VAS)

  6th post-operataive month

• Complications

  6th post-operataive month

Study Arms (1)

Multidirectional

Arthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair.

Procedure: Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair

Interventions

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.

Multidirectional

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary teaching hospital patients, athletes and non-athletes.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04022-001, Brazil

Location

MeSH Terms

Conditions

Ankle Injuries; Joint Instability; Sprains and Strains

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Nacime Salomão Barbachan Mansur, MD, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the article is published.
• Access Criteria: A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.

Locations

BR (1)