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

NCT02470338 | Withdrawn

• 1 other identifier: 404631-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Talar Tilt Exam

  the angle formed by the tibial plafond and talar dome is measured as inversion force is applied to the hindfoot at 10-20 degrees of plantarflexion. A tilt of 0-23 degrees is considered normal though most ankles measure 0-5 degrees.

  Changes in Talar Tilt Exam scores from initial pre-op through the end of study. (Pre- Operative, Day of Surgery, Post-Op Month 3, Post Op Month 6, Post Op Month 12, Post Op Month 24)

• Anterior Drawer Exam

  a test in which a patient is seated with the knee flexed, and the tibia is fixed with one hand while the ankle is grasped with the other hand, plantarflexed 10 degrees, and the talus is translated anteriorly under fluoroscopy. The degree of translation in mm is measured. To put this in perspective, a translation of \>8mm is considered diagnostic for an anterior talofibular ligament (ATFL) tear.

  Changes in Anterior Drawer Exam scores from initial pre-op through the end of study. (Pre- Operative, Day of Surgery, Post-Op Month 3, Post Op Month 6, Post Op Month 12, Post Op Month 24)

• Visual Analog Scale

  a psychometric response scale in which a patient indicates their agreement with a statement along a continuous line. In our case, we will record how satisfied the patient is with their outcome/present post-operative state on a scale of 1-100.

  Changes in Visual Analog Scale scores from initial pre-op through the end of study. (Pre- Operative, Day of Surgery, Post-Op Month 3, Post Op Month 6, Post Op Month 12, Post Op Month 24)

• American Orthopaedic Foot and Ankle Society

  Hindfoot Score is a subjective outcome scale evaluating pain, function, and alignment

  Changes in American Orthopaedic Foot and Ankle Society scores from initial pre-op through the end of study. (Pre- Operative, Day of Surgery, Post-Op Month 3, Post Op Month 6, Post Op Month 12, Post Op Month 24)

Study Arms (2)

MBP plus ankle arthroscopy (Group A)

ACTIVE COMPARATOR

Group A will receive a diagnostic ankle arthroscopy followed by the Modified Brostrӧm Procedure (MBP). In the ankle arthroscopy, multiple pictures are taken inside of the joint to note possible pathologic processes (for example - osteochondral lesions of the talus). Ankle arthroscopy involves one incision in the middle of the ankle anteriomedial (middle) incision and one incision on the outside of the ankle. Each incision (a small cut in the skin) is roughly 5mm in length (which is about 0.2 inches). After the incision is made, the participant will receive a diagnostic ankle arthroscopy.If the surgeon detects an abnormality inside the joint, he will operate on the abnormality with the arthroscope according to the generally accepted principles for treating the abnormality.

Procedure: MBP plus arthroscopy (Group A)

MBP alone (Group B)

SHAM COMPARATOR

Group B will receive sham skin incisions on the ankle a Modified Brostrӧm Procedure (MBP) alone (that is, there will be no diagnostic ankle arthroscopy) followed by the Modified Brostrӧm Procedure (MBP). If a participant is assigned to Group B, the participant will receive two small superficial skin incisions at the sites where the investigators would normally insert instruments for the ankle arthroscopy. As with Group A, there will be one anteriomedial (middle) incision on the middle of the ankle and one anteriolateral (side) incision to on the outside of the ankle. Each incision will be roughly 5mm in length and 5 mm in depth, but will not violate subcutaneous tissue. The width of these incisions will be the width of the blade, at 1mm. However, unlike Group A, the participants in Group B will not have any instruments inserted into their ankle and will not have any operation to repair or remove damaged tissue.

Procedure: MBP alone (Group B)

Interventions

MBP plus arthroscopy (Group A) PROCEDURE

MBP plus ankle arthroscopy (Group A)

MBP alone (Group B) PROCEDURE

MBP alone (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to independently consent for surgery
• Able to demonstrate an understanding of study procedures
• Adult patient 18 years of age or older
• All active duty soldiers, Veterans, dependents
• Ability to comply with study procedures for the entire length of the study
• Presence of lateral ankle instability meeting operative criteria listed in 6.2.1 with documented failed conservative measures such as: physical therapy, ankle braces, and rest

You may not qualify if:

• Unable to obtain medical clearance for surgery
• Recent (1 month) febrile illness that precludes or delays participation
• History of or suspected of drug/alcohol abuse, as these patients may not be compliant with physical therapy. All patients are required to be immobilized for 6 weeks after surgery
• Pregnant women, this is an elective procedure and a MBP or ankle arthroscopy is not typically offered to pregnant women. Screening for pregnancy is done as part of standard of care

Sponsors & Collaborators

• Edna Rath: lead

Study Sites (1)

William Beaumont Army Medical Center

El Paso, Texas, 79920-5001, United States

Location

Related Publications (11)

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  BACKGROUND

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  PMID: 18832604 BACKGROUND

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• O'Neill PJ, Van Aman SE, Guyton GP. Is MRI adequate to detect lesions in patients with ankle instability? Clin Orthop Relat Res. 2010 Apr;468(4):1115-9. doi: 10.1007/s11999-009-1131-0. Epub 2009 Oct 23.

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• Richardson EG. Orthopaedic Knowledge Update 3. 2004. American Academy of Orthopaedic Surgeons. Rosemont, IL.

  BACKGROUND

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MeSH Terms

Interventions

Arthroscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• MAJ Justin D Orr, MD, MC, USA

  Program Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Human Protection Director

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 12, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)