NCT02470338

Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability

A Single-Blinded Randomized Controlled Trial Comparing Modified Brostrӧm Procedure With and Without Diagnostic Arthroscopy for Treatment of Lateral Ankle Instability

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Edna Rath · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to show that the investigators believe the Modified Brostrӧm Procedure (MBP) can be completed without a routine ankle arthroscopy. Routine ankle arthroscopy, if determined not to be necessary in all cases, is a waste of resources in terms of operating room, surgeon, and staff time as well causing an increase in hospital financial expenses. Most importantly, this procedure is morbid. Ankle arthroscopy forces a patient's foot into distraction for up to one hour, exposes the patient to potentially longer anesthesia exposure that is unnecessary, increases infectious risks, and requires exposure at the portal sites near superficial nerves.

Detailed description

The purpose of this investigation is to determine if ankle arthroscopy is necessary in the treatment of routine ankle instability without evidence of intra-articular pathology on MRI. Our study population will include those individuals whose ankle MRI is inconclusive or negative for intra-articular pathologies, and intra-articular ankle pain is not a predominant presenting symptom. Although it is our current practice at WBAMC not to conduct an ankle arthroscopy on this group of patients, there is a debate in the literature on whether the arthroscopy should be conducted. Thus, the purpose of this study is to examine the MBP with and without ankle arthroscopy.

Conditions

• Lateral Ankle Instability

Interventions

Type	Name	Description
PROCEDURE	MBP plus arthroscopy (Group A)
PROCEDURE	MBP alone (Group B)

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-04-01
• Completion: 2018-06-01
• First posted: 2015-06-12
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States