Recruiting

Dynamic Compression Nail

Sponsor:

MedShape, Inc

Code:

NCT04784273

Conditions

Ankle Arthritis

Foot Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tibiotalocalcaneal Arthrodesis

DynaNail

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.

Conditions

Ankle Arthritis

Foot Arthritis

Study ID

NCT04784273

Start date

Sep 23, 2020

Status verified date

Mar, 2021

Completion date

Sep, 2023

Anticipated

Primary completion date

Sep, 2023

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, provide a written consent, and willing to comply with the study protocol
  • 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

30 participants

Anticipated

Interventions and Outcome Measures

Arms

All study patients

Device - DynaNail - Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Interventions

Tibiotalocalcaneal Arthrodesis

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

DynaNail

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Primary outcome measure

  • Fusion / Union [ Time Frame: Time Frame: Pre-operative up to 1 year post surgery ]

Central Contacts and Locations

Central contacts

Kenneth Dupont, PhD, MS

6782353336kenneth.dupont@medshape.com

Melanese Leonard-Warren, RN, MSN

2059752671mnleonard@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Melanese Leonard-Warren, RN, MSN

205-975-2671mnleonard@uabmc.edu

Ashish Shah, MD

ashishshah@uabmc.edu

Principal Investigator:

Ashish Shah, MD

More Information

Sponsor

MedShape, Inc

Last update posted

Mar 5, 2021

Last verified

Mar, 2021

Keywords

  • Subtalar Arthrodesis
  • Tibiotalar Arthrodesis
  • Sustained Dynamic Compression
  • Internal Fixation
  • Intramedullary Nail

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 2021-03-05.