Arthroscopic Versus Open Brostrom for Ankle Instability

NCT03643926 | Recruiting DMC

• 1 other identifier: 13072018
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ankle; instability; brostrom; open; arthroscopic

Outcome Measures

Primary Outcomes (1)

• Complications (change)

  * Dehiscence: inability to heal the soft tissue coverage until the end of the 4th post-operative week. * Peripherical nerve damage: hypoesthesia or paresthesia not solved until the end of the 6th month after the surgery. * Infection: clinical signs of site infection or pus drainage at the wound that required the use of antibiotics. * Re-rupture: an ankle sprain event during the follow-up.

  3, 6, 12, 24 and 48 weeks

Secondary Outcomes (6)

• Cumberland Ankle Instability Tool - CAIT (change)

  3, 6, 12, 24 and 48 weeks

• American Orthopedic Foot and Ankle Society - AOFAS (change)

  3, 6, 12, 24 and 48 weeks

• Visual Analogue Scale - VAS (change)

  3, 6, 12, 24 and 48 weeks

• Foot Function Index - FFI (change)

  3, 6, 12, 24 and 48 weeks

• 36 Item Short Form Health Survey - SF36 (change)

  3, 6, 12, 24 and 48 weeks

Study Arms (2)

Arthroscopic Brostrom

EXPERIMENTAL

Procedure: Arthroscopic Brostrom

Open Brostrom

ACTIVE COMPARATOR

Procedure: Open Brostrom

Interventions

Arthroscopic Brostrom PROCEDURE

Brostrom-Gould lateral ligament ankle reconstruction performed by arthroscopic view

Arthroscopic Brostrom

Open Brostrom PROCEDURE

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

Open Brostrom

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must be older than 18 and younger than 65 years of age, both genders;
• Participants must be experiencing instability symptoms at the ankle over the last six months;
• Clinical diagnosis of ankle instability, defined as the presence of at least one previous ankle sprain associated with a current instability sensation by the patient and the presence of a positive anterior drawer test; the previous lateral ligament injury must be confirmed by Magnetic Resonance Imaging (MRI) findings.

You may not qualify if:

• Previous surgery involving the affected foot or ankle;
• History or documented evidence of autoimmune or peripheral vascular diseases;
• History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.);
• Associated injuries, such as osteochondral lesions, tendon ruptures and fractures.
• Associated instability, such as syndesmotic and medial instability.
• Cavovarus foot;
• BMI over 35;
• Previous infiltration in the ankle over the six months preceding the initial assessment;
• Pregnancy;
• Any condition that represents a contraindication of the proposed therapies;
• Impossibility or incapacity to sign the informed Consent Form;
• History or documented evidence of blood coagulation disorders (including treatment with anti-coagulants, but excluding aspirin);
• Use of heart pacemaker;
• Presence of infectious process (superficial on skin and cellular tissue, or deep in the bone) in the region to be treated;

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (2)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

NOT YET RECRUITING

Federal University of Sao Paulo

São Paulo, São Paulo, 04022-001, Brazil

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Ankle Injuries; Joint Instability

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcel JS Tamaoki, PhD

  Federal University Sao Paulo

  STUDY CHAIR

• Caio Nery, PhD

  Federal University Sao Paulo

  STUDY DIRECTOR

• Fabio Matsunaga, PhD

  Federal University Sao Paulo

  STUDY DIRECTOR

• Roberto Zambelli, MD

  Federal University of Minas Gerais

  STUDY DIRECTOR

Central Study Contacts

Nacime SB Mansur, MD

CONTACT

+5511994500853; nacime@nacime.com.br

Daniel S Baumfeld, PhD

CONTACT

+5531991968408; danielbaumfeld@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 23, 2018
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 5, 2027
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After statistical analysis closure.
• Access Criteria: Registered researches that request access.

Locations

BR (2)