Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID03643926

Arthroscopic Versus Open Brostrom for Ankle Instability: a Randomized Clinical Trial

Led by Federal University of São Paulo · Updated on 2024-09-27

98

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ankle sprains are common injuries that can lead to chronic ankle instability requiring surgery. This study compares two surgical methods for treating this condition: the traditional open Brostrom-Gould technique and the newer arthroscopic Brostrom approach. The goal is to evaluate which method provides better pain relief and improved function. The trial is randomized, blinded, and conducted at multiple centers to provide reliable comparisons. Participants will be randomly assigned to receive either the open Brostrom repair or the arthroscopic Brostrom procedure. Both surgeries involve ligament repair with similar anesthesia and post-operative care including weight-bearing and motion exercises starting within weeks after surgery. Patients will be evaluated at 3, 6, 12, 24, and 48 weeks after surgery to monitor healing, complications, and functional outcomes. During the study, participants will complete questionnaires assessing ankle stability, pain, foot function, and overall health quality. Researchers will track major complications such as infections or nerve damage, along with minor issues like suture discomfort. The assessments will use validated tools including the Cumberland Ankle Instability Tool, American Orthopedic Foot and Ankle Society score, Visual Analogue Scale, Foot Function Index, and SF-36 survey. The total follow-up period is 48 weeks, allowing careful monitoring of recovery and surgical effects.

CONDITIONS

Brief Title

Arthroscopic Versus Open Brostrom for Ankle Instability

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals must be older than 18 and younger than 65 years of age, both genders
  • Experiencing ankle instability symptoms for at least six months
  • Clinical diagnosis of ankle instability with at least one previous ankle sprain, positive anterior drawer test, and MRI confirmation of lateral ligament injury
Not Eligible

You will not qualify if you...

  • Previous surgery involving the affected foot or ankle
  • History or evidence of autoimmune or peripheral vascular diseases
  • History or evidence of peripheral neuropathy or systemic inflammatory diseases such as rheumatoid arthritis
  • Associated injuries like osteochondral lesions, tendon ruptures, or fractures
  • Associated syndesmotic or medial ankle instability
  • Cavovarus foot deformity
  • Body mass index (BMI) over 35
  • Ankle infiltration treatment within six months before assessment
  • Pregnancy
  • Any contraindication to the proposed therapies
  • Inability or unwillingness to sign the informed consent form
  • History or evidence of blood coagulation disorders (excluding aspirin use)
  • Use of a heart pacemaker
  • Presence of active infection in the treatment area (skin, cellular tissue, or bone)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 month from diagnosis to surgery, with post-operative care continuing through 6 weeks

Participants undergo either the arthroscopic or open Brostrom lateral ligament ankle reconstruction surgery and initial post-operative recovery, including use of a post-operative boot, weight-bearing starting the first week, and range of motion exercises starting the third week.

1 surgery visit and follow-up visits at weeks 3 and 6

Follow-up

Duration - Up to 48 weeks post-surgery

Participants are evaluated for complications and functional outcomes using questionnaires and physical assessments at multiple time points after surgery.

Visits at 3, 6, 12, 24, and 48 weeks post-operative

Trial Site Locations

Total: 2 locations

1

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil, 31270-901

Not Yet Recruiting

2

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil, 04022-001

Actively Recruiting

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Research Team

N

Nacime SB Mansur, MD

D

Daniel S Baumfeld, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Comparison of All-Inside Arthroscopic and Open Techniques for the Modified Broström Procedure for Ankle Instability.

Eui Dong Yeo, Kyung-Tai Lee, Il-Hoon Sung...

https://pubmed.ncbi.nlm.nih.gov/27623732

2016 consensus statement of the International Ankle Consortium: prevalence, impact and long-term consequences of lateral ankle sprains.

Phillip A Gribble, Chris M Bleakley, Brian M Caulfield...

https://pubmed.ncbi.nlm.nih.gov/27259750

Recovery From a First-Time Lateral Ankle Sprain and the Predictors of Chronic Ankle Instability: A Prospective Cohort Analysis.

Cailbhe Doherty, Chris Bleakley, Jay Hertel...

https://pubmed.ncbi.nlm.nih.gov/26912285