Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability
NCT ID: NCT02470338
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-06-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
MBP plus arthroscopy (Group A)
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.
MBP alone (Group B)
Interventions
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MBP plus arthroscopy (Group A)
MBP alone (Group B)
Eligibility Criteria
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Inclusion Criteria
2. Able to demonstrate an understanding of study procedures
3. Adult patient 18 years of age or older
4. All active duty soldiers, Veterans, dependents
5. Ability to comply with study procedures for the entire length of the study
6. 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
2. Recent (1 month) febrile illness that precludes or delays participation
3. 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
4. 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
18 Years
ALL
Yes
Sponsors
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Edna Rath
FED
Responsible Party
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Edna Rath
Human Protection Director
Principal Investigators
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MAJ Justin D Orr, MD, MC, USA
Role: PRINCIPAL_INVESTIGATOR
Program Director
Locations
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William Beaumont Army Medical Center
El Paso, Texas, United States
Countries
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References
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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.
Other Identifiers
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404631-1
Identifier Type: -
Identifier Source: org_study_id
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