Recruiting

Sustained Dynamic Compression Nail

Sponsor:

MedShape, Inc

Code:

NCT04831645

Conditions

Ankle Arthritis

Arthritis Foot

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DynaNail

Tibiotalocalcaneal Arthrodesis

Study Details

Brief 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

Study ID

NCT04831645

Start date

May 24, 2021

Status verified date

Apr, 2021

Completion date

May 24, 2024

Anticipated

Primary completion date

May 24, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Interventions

DynaNail

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Tibiotalocalcaneal Arthrodesis

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

Primary outcome measure

  • Fusion [ Time Frame: Pre-Operative to 1 year post-surgery ]

Central Contacts and Locations

Central contacts

Locations

Orthopedic Foot and Ankle Center

Recruiting

Worthington, Ohio, United States, 43085

Contacts

Gregory C Berlet, MD

berletgc@orthofootankle.com

Principal Investigator:

Gregory C Berlet, MD

More Information

Sponsor

MedShape, Inc

Last update posted

May 25, 2021

Last verified

Apr, 2021

Keywords

  • Subtalar Arthrodesis
  • Intramedullary Nail
  • Ankle Arthrodesis
  • Internal Fixation
  • Sustained Compression
  • Longitudinal Computed Tomography
  • Tibiotalar Arthrodesis
  • Joint Fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MedShape, Inc on 2021-05-25.