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Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation

NCT04933045 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2021-06-21

No results posted yet for this study

Summary

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.

Conditions

  • Syndesmotic Injuries

Interventions

DEVICE

Arthrex InternalBrace

Placement of Arthrex InternalBrace for anatomic distal tibiofibular ligament augmentation to stabilize the ankle syndesmosis during surgery.

Sponsors & Collaborators

  • St. Clair Orthopaedics

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933045 on ClinicalTrials.gov