- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470338
Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability
May 8, 2017 updated by: Justin Orr, William Beaumont Army Medical Center
A Single-Blinded Randomized Controlled Trial Comparing Modified Brostrӧm Procedure With and Without Diagnostic Arthroscopy for Treatment of Lateral Ankle Instability
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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El Paso, Texas, United States, 79920-5001
- William Beaumont Army Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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.
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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)
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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)
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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.
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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)
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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)
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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.
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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)
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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)
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Hindfoot Score is a subjective outcome scale evaluating pain, function, and alignment
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MAJ Justin D Orr, MD, MC, USA, Program Director
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429.
- DiGiovanni CW, Brodsky A. Current concepts: lateral ankle instability. Foot Ankle Int. 2006 Oct;27(10):854-66. doi: 10.1177/107110070602701019. No abstract available.
- DIGiovanni BF, Fraga CJ, Cohen BE, Shereff MJ. Associated injuries found in chronic lateral ankle instability. Foot Ankle Int. 2000 Oct;21(10):809-15. doi: 10.1177/107110070002101003.
- 4. Kitaoka HB. The Foot and Ankle. Master Techniques in Orthopaedic Surgery. 2013. 3rd edition: 515-536. Lippincott Williams & Wilkins. Philadelphia, PA.
- Komenda GA, Ferkel RD. Arthroscopic findings associated with the unstable ankle. Foot Ankle Int. 1999 Nov;20(11):708-13. doi: 10.1177/107110079902001106.
- Maffulli N, Ferran NA. Management of acute and chronic ankle instability. J Am Acad Orthop Surg. 2008 Oct;16(10):608-15. doi: 10.5435/00124635-200810000-00006.
- Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
- 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.
- Richardson EG. Orthopaedic Knowledge Update 3. 2004. American Academy of Orthopaedic Surgeons. Rosemont, IL.
- Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
- van Dijk CN, Bossuyt PM, Marti RK. Medial ankle pain after lateral ligament rupture. J Bone Joint Surg Br. 1996 Jul;78(4):562-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
April 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
May 28, 2015
First Submitted That Met QC Criteria
June 9, 2015
First Posted (Estimate)
June 12, 2015
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 404631-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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