Recruiting

Dynamic Compression Nail

Sponsor:

MedShape, Inc

Code:

NCT03747952

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 dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Conditions

Ankle Arthritis

Foot Arthritis

Study ID

NCT03747952

Start date

May 14, 2019

Status verified date

Sep, 2020

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older
  • Ankle and Subtalar arthritis
  • Failed non-operative management
  • Able to understand the requirements of the study, provide written consent, and willing to comply with study protocol

Exclusion Criteria:

  • Patients who do not meet the minimum age of 18 years
  • Patients not healthy enough to undergo surgery
  • 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

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 [ Time Frame: Pre-operative up to 2 years post surgery ]

Central Contacts and Locations

Central contacts

Kenneth M Dupont, Ph.D.

6782353336kenneth.dupont@medshape.com

Safee F Ahmed

409-747-3221sfahmed@utmb.edu

Locations

The University of Texas Medical Branch at Galveston

Recruiting

Galveston, Texas, United States, 77555-0342

Contacts

Safee F Ahmed

409-747-3221sfahmed@utmb.edu

Lisa Hernandez

409-772-1618lghernan@utmb.edu

Principal Investigator:

Vinod K Panchbhavi, MD

More Information

Sponsor

MedShape, Inc

Last update posted

Mar 5, 2021

Last verified

Sep, 2020

Keywords

  • Tibiotalocalcaneal arthrodesis
  • Intramedullary Nail
  • Sustained Compression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MedShape, Inc on 2021-03-05.