Status:
UNKNOWN
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
Lead Sponsor:
Arthrex, Inc.
Conditions:
Lateral Ankle Instability
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lateral ankle ligament stabilization procedures are well described in the orthopaedic literature. Although success rates are high, the incidence of recurrent instability is well documented. In additio...
Detailed Description
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 Brostr...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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)
- Exclusion criteria
- 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
- Neuropathy
Exclusion
Key Trial Info
Start Date :
March 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04770818
Start Date
March 10 2016
End Date
March 10 2023
Last Update
March 16 2021
Active Locations (3)
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1
Illinois Bone & Joint Institute
Chicago, Illinois, United States, 60618
2
Desert Orthopaedic Center
Las Vegas, Nevada, United States, 89121
3
Logan Regional Orthopedics
Logan, Utah, United States, 84341