Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability
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|ClinicalTrials.gov Identifier: NCT02470338|
Recruitment Status : Unknown
Verified May 2017 by Justin Orr, William Beaumont Army Medical Center.
Recruitment status was: Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lateral Ankle Instability||Procedure: MBP plus arthroscopy (Group A) Procedure: MBP alone (Group B)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Single-Blinded Randomized Controlled Trial Comparing Modified Brostrӧm Procedure With and Without Diagnostic Arthroscopy for Treatment of Lateral Ankle Instability|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: MBP plus ankle arthroscopy (Group A)
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)
Sham Comparator: MBP alone (Group B)
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)
- Talar Tilt Exam [ Time Frame: 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) ]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.
- Anterior Drawer Exam [ Time Frame: 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) ]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.
- Visual Analog Scale [ Time Frame: 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) ]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.
- American Orthopaedic Foot and Ankle Society [ Time Frame: 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) ]Hindfoot Score is a subjective outcome scale evaluating pain, function, and alignment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470338
|United States, Texas|
|William Beaumont Army Medical Center|
|El Paso, Texas, United States, 79920-5001|
|Principal Investigator:||MAJ Justin D Orr, MD, MC, USA||Program Director|