Recruiting

Dynamic Compression Nail

Sponsor:

MedShape, Inc

Code:

NCT03686241

Conditions

Ankle Arthritis

Foot Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tibiotalocalcaneal (TTC) 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

NCT03686241

Start date

May 22, 2017

Status verified date

Feb, 2021

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

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 (TTC) 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

Alicia Weeks

2083023128alicia.weeks@saintalphonsus.org

Locations

Saint Alphonsus Medical Group Orthopedics Coughlin Foot and Ankle Clinic

Recruiting

Boise, Idaho, United States, 83706

Contacts

Alicia Weeks

208-302-3128Alicia.Weeks@saintalphonsus.org

Paige Nesbitt

2083678386Paige.Nesbitt@saintalphonsus.org

Principal Investigator:

Christopher Hirose, MD

More Information

Sponsor

MedShape, Inc

Last update posted

Mar 5, 2021

Last verified

Feb, 2021

Keywords

  • Tibiotalocalcaneal arthrodesis
  • Intramedullary Nail
  • Sustained Compression

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.