Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

NCT03747952 | Unknown DMC FDA Device

• 1 other identifier: 18-0050
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Tibiotalocalcaneal arthrodesis; Intramedullary Nail; Sustained Compression

Outcome Measures

Primary Outcomes (1)

• Fusion

  Joint Fusion, as measured by radiograph and CT scan

  Pre-operative up to 2 years post surgery

Secondary Outcomes (3)

• Pain - VAS

  Pre-operative up to 2 years post surgery

• Function - SF-36

  Pre-operative up to 2 years post surgery

• FAAM

  Pre-operative up to 2 years post surgery

Interventions

Tibiotalocalcaneal arthrodesis PROCEDURE

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

DynaNail DEVICE

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone age 18 and over who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore exclusion criteria will include patients who are not healthy enough to undergo surgery. Patients of all racial, religious, and cultural backgrounds will be included in this study. Approximately 30 patients will be recruited for the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedShape, Inc: lead
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (1)

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0342, United States

RECRUITING

Study Officials

• Vinod K Panchbhavi, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth M Dupont, Ph.D.

CONTACT

6782353336; kenneth.dupont@medshape.com

Safee F Ahmed

CONTACT

409-747-3221; sfahmed@utmb.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: May 14, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 5, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)