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

Lateral Ankle Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02470338
• Other study ID #: 404631-1
• Status: Active, not recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: May 8, 2017
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: William Beaumont Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Instability
• Lateral Ankle Instability

Intervention

Procedure:
• MBP plus arthroscopy (Group A)

• MBP alone (Group B)

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

4. Kitaoka HB. The Foot and Ankle. Master Techniques in Orthopaedic Surgery. 2013. 3rd edition: 515-536. Lippincott Williams & Wilkins. Philadelphia, PA.

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. — View 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. — View Citation

DiGiovanni CW, Brodsky A. Current concepts: lateral ankle instability. Foot Ankle Int. 2006 Oct;27(10):854-66. Review. — View Citation

Komenda GA, Ferkel RD. Arthroscopic findings associated with the unstable ankle. Foot Ankle Int. 1999 Nov;20(11):708-13. — View Citation

Maffulli N, Ferran NA. Management of acute and chronic ankle instability. J Am Acad Orthop Surg. 2008 Oct;16(10):608-15. Review. — View 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. — View 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. — View Citation

Richardson EG. Orthopaedic Knowledge Update 3. 2004. American Academy of Orthopaedic Surgeons. Rosemont, IL.

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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)