Lateral Ankle Instability
Conditions
Brief 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.
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.
Interventions
PROCEDUREMBP plus arthroscopy (Group A)
PROCEDUREMBP alone (Group B)
Sponsors
Edna Rath
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Talar Tilt Exam | 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) | 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. |
| Anterior Drawer Exam | 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) | 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. |
| Visual Analog Scale | 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) | 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. |
| American Orthopaedic Foot and Ankle Society | 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) | Hindfoot Score is a subjective outcome scale evaluating pain, function, and alignment |
Countries
United States
Outcome results
None listed