Recruiting

Dynamic Compression Nail

Sponsor:

MedShape, Inc

Code:

NCT04338607

Conditions

Foot Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Subtalar (Talocalcaneal) arthrodesis

DynaNail Mini

Study Details

Brief summary:

The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.

Conditions

Foot Arthritis

Study ID

NCT04338607

Start date

Apr 2, 2020

Status verified date

Apr, 2020

Completion date

Apr 2, 2024

Anticipated

Primary completion date

Apr 2, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • End-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study
  • Meets indications for subtalar arthrodesis to receive the DynaNail Mini 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
  • Pregnant women

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

All study patients

All study patients will be in one group.

Interventions

Subtalar (Talocalcaneal) arthrodesis

Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail

DynaNail Mini

Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail

Primary outcome measure

  • Fusion [ Time Frame: From surgery up to one year post-surgery ]

Central Contacts and Locations

Central contacts

Kenneth M Dupont, PhD, MS

6782353336kenneth.dupont@medshape.com

Chancey Sweeney, MPH, MHA

9167346017cassweeney@ucdavis.edu

Locations

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Christopher Kreulen, MD, MS

916-734-6805ckreulen@ucdavis.edu

Chancey Sweeney, MPH, MHA

9167346017cassweeney@ucdavis.edu

More Information

Sponsor

MedShape, Inc

Last update posted

Mar 5, 2021

Last verified

Apr, 2020

Keywords

  • Subtalar Arthrodesis
  • Intramedullary Nail
  • Sustained Dynamic 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.