Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arthrex, Inc.
It is hypothesized that use of InternalBrace Ligament Augmentation in addition to standard anatomic modified Brostrum repair allows for earlier return to pre-injury level compared to a standard Brostrum procedure. It is also secondarily hypothesized that intermediate and long term incidence of recurrent instability will be lower with use of internal brace augmentation of standard modified Brostrum lateral ankle ligament reconstruction.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects that consent to the study
Ages 18 and older
Subjects who are candidates for primary ankle instability reconstruction utilizing a standard Brostrum technique
Able to understand, complete and sign/date the Informed Consent Form (ICF)
You may not be if
Subjects that are pregnant or planning to become pregnant within 58 weeks after surgery
Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
Systemic laxity
Bony correction (i.e. calcaneal osteotomy)
Major additional tendon surgery such as tenodesis or repair of the peroneal tendon (synovectomy is allowable)
Major arthroscopic surgery such as treatment of chondral defects, including microfracture (arthroscopic synovectomy and arthroscopically treated osteophyte resection are allowable)
Revision surgery
Inadequate tissue for standard Brostrum reconstruction
