Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability
NCT02470338 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-09-25
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.
Conditions
- Lateral Ankle Instability
Interventions
- PROCEDURE
-
MBP plus arthroscopy (Group A)
- PROCEDURE
-
MBP alone (Group B)
Sponsors & Collaborators
-
Edna Rath
lead FED
Principal Investigators
-
MAJ Justin D Orr, MD, MC, USA · Program Director
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2018-04-30
- Completion
- 2018-06-30
Countries
- United States
Study Locations
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