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

NCT04831645 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2021-05-25

No results posted yet for this study

Summary

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.

Conditions

  • Ankle Arthritis
  • Arthritis Foot

Interventions

DEVICE

DynaNail

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

PROCEDURE

Tibiotalocalcaneal Arthrodesis

Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.

Sponsors & Collaborators

  • CurveBeam LLC

    collaborator UNKNOWN

  • Orthopedic Foot and Ankle Center, Ohio

    collaborator OTHER

  • MedShape, Inc

    lead INDUSTRY

Principal Investigators

  • Gregory C Berlet, MD · Orthopedic Foot and Ankle Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2024-05-24
Completion
2024-05-24
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 NCT04831645 on ClinicalTrials.gov