Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation

Status unconfirmed

Conditions studied: Syndesmotic Injuries

In brief

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.

Key facts

Study ID

NCT04933045

Run by

St. Clair Orthopaedics

People needed

32

Starts

2021-07-01

Expected to finish

2021-12-31

Last updated by the study team

2021-06-21

Who can join

Age: 18 and older, up to 105. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation

You may not qualify if…

• Skeletally immature patients, patients with nonoperatively managed ankle injuries

Where it is running

• St Clair Orthopedics and Sports Medicine — Saint Clair Shores, Michigan, United States

Full record on ClinicalTrials.gov

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