Arthroscopic Versus Open Brostrom for Ankle Instability

Summary

Background: Ankle sprains are among the most prevalent lesions in primary care. A substantial number of these ligament lesions will develop ankle instability and require a surgical procedure. The Brostrom-Gould technique is the standard surgical approach for this condition, providing excellent results over the years. Thru the last decades, the arthroscopic Brostrom has gain popularity and support by several studies. Yet, there is no consensus regarding the best procedure to treat ankle instability nowadays.

Hypothesis: The arthroscopic Brostrom technique will present better levels of pain and function when compared to the standard open approach.

Design: blinded, in parallel groups, multicentric, randomized, clinical trial.

Materials and Methods: 98 patients with a diagnosis of chronic ankle instability, referred from primary or secondary health care services, will be assessed and enrolled in this study. Participants will be divided in two groups (randomized by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the open Brostrom repair technique and the other comprehending the arthroscopic Brostrom approach. The assessments will occur in 3, 6, 12, 24 and 48 weeks. Patients will be evaluated primarily by complications and secondarily the Cumberland Ankle Instability Tool (CAIT), American Orthopedic Foot and Ankle Society (AOFAS), the Visual Analogue Scale (VAS), the Foot Function Index (FFI) and the 36 Item Short Form Health Survey (SF-36). The investigators will use Comparison of Two Proportions via relative frequency analysis, the Pearson Correlation the Chi-Square test and the ANOVA for statistical analyses.

Discussion: This study intends to establish if the arthroscopic Brostrom technique can produce excellent and reliable results when treating chronic ankle instability. A shorter surgical time, a better cosmetic appearance and a smaller soft tissue injury would support the choice for this procedure if the outcomes could be compared to the open approach.

Conditions

• Ankle Sprains
• Instability, Joint
• Ligament Injury
• Surgery

Interventions

PROCEDURE

Arthroscopic Brostrom

Brostrom-Gould lateral ligament ankle reconstruction performed by arthroscopic view

PROCEDURE

Open Brostrom

Brostrom-Gould lateral ligament ankle reconstruction performed by an open approach.

Sponsors & Collaborators

• Federal University of São Paulo

  lead OTHER

Principal Investigators

• Marcel JS Tamaoki, PhD · Federal University Sao Paulo

• Caio Nery, PhD · Federal University Sao Paulo

• Fabio Matsunaga, PhD · Federal University Sao Paulo

• Roberto Zambelli, MD · Federal University of Minas Gerais

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2026-12-01

Completion

2027-12-05

Countries

• Brazil

Study Locations