The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

Status unconfirmed

Conditions studied: Ankle Arthritis, Arthritis Foot

In brief

The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic imaging. Of particular focus will be assessment of compressive element recovery and its relation to fusion development over time and weight-bearing status. Additionally, the study will incorporate longitudinal fusion assessment to evaluate differences between three-dimensional weight-bearing computed tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the fusion process. Finally, the study will evaluate the differences in WBCT-based fusion assessment between automated and manual methodologies for fusion area calculation.

Key facts

Study ID

NCT04831645

Run by

MedShape, Inc

People needed

45

Starts

2021-05-24

Expected to finish

2024-05-24

Last updated by the study team

2021-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets indications for TTC arthrodesis and receives the DynaNail implant
• Able to understand the requirements of the study
• Willing to comply with the study protocol
• Sign an Informed consent
• 18 years of age or older

You may not qualify if…

• Investigator determines that the subject is unlikely to comply with the requirements of the study
• Non-English speaker
• Blind
• Illiterate
• Prisoner

Where it is running

• Orthopedic Foot and Ankle Center — Worthington, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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