Syndesmotic Injuries Clinical Trial
Official title:
Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation
The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases. The secondary objective of the study is to evaluate clinically the InternalBraceTm to facilitate the direct syndesmotic fixation/augmentation.
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 105 Years |
Eligibility | Inclusion Criteria: - Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation Exclusion Criteria: - Skeletally immature patients, patients with nonoperatively managed ankle injuries |
Country | Name | City | State |
---|---|---|---|
United States | St Clair Orthopedics and Sports Medicine | Saint Clair Shores | Michigan |
Lead Sponsor | Collaborator |
---|---|
St. Clair Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Indications and outcomes of operative fixation of syndesmotic injuries | Evaluate indicatinos and outcomes of operative fixation of syndesmotic injuries at least in part with direct anatomic augmentation in acute and subacute traumatic ankle fracture cases. | 1 year | |
Secondary | InternalBrace | Evaluate clinically the InternalBrace to facilitate the direct syndesmotic fixation/augmentation. | 1 yeaer |
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