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This study is to show that the investigators believe the Modified BrostrÓ§m 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBP plus ankle arthroscopy (Group A) | Active Comparator | Group A will receive a diagnostic ankle arthroscopy followed by the Modified BrostrÓ§m 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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| MBP alone (Group B) | Sham Comparator | Group B will receive sham skin incisions on the ankle a Modified BrostrÓ§m Procedure (MBP) alone (that is, there will be no diagnostic ankle arthroscopy) followed by the Modified BrostrÓ§m 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBP plus arthroscopy (Group A) | Procedure |
| ||
| MBP alone (Group B) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MAJ Justin D Orr, MD, MC, USA | Program Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Army Medical Center | El Paso | Texas | 79920-5001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19657121 | Result | 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. | |
| 17054892 | Result | 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. |
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| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Procedure |
|
| 11128010 | Result | 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. |
| Result | 4. Kitaoka HB. The Foot and Ankle. Master Techniques in Orthopaedic Surgery. 2013. 3rd edition: 515-536. Lippincott Williams & Wilkins. Philadelphia, PA. |
| 10582846 | Result | Komenda GA, Ferkel RD. Arthroscopic findings associated with the unstable ankle. Foot Ankle Int. 1999 Nov;20(11):708-13. doi: 10.1177/107110079902001106. |
| 18832604 | Result | 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. |
| 12110735 | Result | 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. |
| 19851818 | Result | 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. |
| Result | Richardson EG. Orthopaedic Knowledge Update 3. 2004. American Academy of Orthopaedic Surgeons. Rosemont, IL. |
| 24369076 | Result | 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. |
| 8682821 | Result | 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. |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |