What is this study comparing for ankle instability?

This study is comparing two surgical methods for chronic ankle instability: the open Brostrom technique and the arthroscopic Brostrom approach. Researchers want to see which method results in better pain control and improved ankle function. The Federal University of São Paulo is leading this research to help improve treatment options for patients with ankle instability.

Who may be eligible for this ankle instability clinical trial?

Adults aged 18 to 65 years with chronic ankle instability symptoms for over six months may be eligible. Both men and women can participate if they have a confirmed diagnosis by MRI and clinical tests. People with prior foot or ankle surgery, certain autoimmune or inflammatory diseases, or pregnancy are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this ankle instability clinical trial?

Study-related care, including the surgery and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

ID03643926

Comparison of Arthroscopic and Open Brostrom Surgery for Treating Chronic Ankle Instability in Adults

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

Participants Needed

Research Sites

52 weeks

Total Duration

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

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

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)

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