Expired Study
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El Paso, Texas 79920


Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: 1. Able to independently consent for surgery 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: 1. Unable to obtain medical clearance for surgery 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


Study is Available At:


Original ID:

404631-1


NCT ID:

NCT02470338


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Single-Blinded Randomized Controlled Trial Comparing Modified Brostrӧm Procedure With and Without Diagnostic Arthroscopy for Treatment of Lateral Ankle Instability


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

William Beaumont Army Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

112


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:MAJ Justin D Orr, MD, MC, USA
Principal Investigator
Program Director

Study Dates

Start Date:June 2015
Completion Date:June 2018
Completion Type:Anticipated
Primary Completion Date:April 2018
Primary Completion Type:Anticipated
Verification Date:May 2017
Last Changed Date:May 8, 2017
First Received Date:May 28, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Hindfoot Score is a subjective outcome scale evaluating pain, function, and alignment
Outcome Type:Primary Outcome
Measure:Visual Analog Scale
Time Frame:Changes in Visual Analog Scale scores from initial pre-op through the end of study. (Pre- Operative,
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Anterior Drawer Exam
Time Frame:Changes in Anterior Drawer Exam scores from initial pre-op through the end of study. (Pre- Operative
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Talar Tilt Exam
Time Frame:Changes in Talar Tilt Exam scores from initial pre-op through the end of study. (Pre- Operative, Day
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Procedure
Name:MBP plus arthroscopy (Group A)
Arm Name:MBP plus ankle arthroscopy (Group A)
Intervention Type:Procedure
Name:MBP alone (Group B)
Arm Name:MBP alone (Group B)

Study Arms

Study Arm Type:Sham Comparator
Arm Name:MBP alone (Group B)
Description: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 ank
Study Arm Type:Active Comparator
Arm Name:MBP plus ankle arthroscopy (Group A)
Description: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 inc

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:William Beaumont Army Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:8682821
Reference Type:Results Reference
Citation:Sihvonen R, Paavola M, Malmivaara A, Itälä A, Joukainen A, Nurmi H, Kalske J, Järvinen 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.
PMID:24369076
Reference Type:Results Reference
Citation:Richardson EG. Orthopaedic Knowledge Update 3. 2004. American Academy of Orthopaedic Surgeons. Rosemont, IL.
Reference Type:Results Reference
Citation: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.
PMID:19851818
Reference Type:Results Reference
Citation: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.
PMID:12110735
Reference Type:Results Reference
Citation:Maffulli N, Ferran NA. Management of acute and chronic ankle instability. J Am Acad Orthop Surg. 2008 Oct;16(10):608-15. Review.
PMID:18832604
Reference Type:Results Reference
Citation:Komenda GA, Ferkel RD. Arthroscopic findings associated with the unstable ankle. Foot Ankle Int. 1999 Nov;20(11):708-13.
PMID:10582846
Reference Type:Results Reference
Citation:4. Kitaoka HB. The Foot and Ankle. Master Techniques in Orthopaedic Surgery. 2013. 3rd edition: 515-536. Lippincott Williams & Wilkins. Philadelphia, PA.
Reference Type:Results Reference
Citation: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.
PMID:11128010
Reference Type:Results Reference
Citation:DiGiovanni CW, Brodsky A. Current concepts: lateral ankle instability. Foot Ankle Int. 2006 Oct;27(10):854-66. Review.
PMID:17054892
Reference Type:Results Reference
Citation: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.
PMID:19657121

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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