The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

NCT04784273 | Unknown FDA Device

• 1 other identifier: IRB-300002689
• 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 sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Conditions

Ankle Arthritis; Foot Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fusion / Union

  Joint Fusion, as measured by radiograph and CT scan

  Time Frame: Pre-operative up to 1 year post surgery

Secondary Outcomes (3)

• Pain - VAS

  Pre-Operative up to one year post-surgery

• Function - SF-36

  Pre-Operative up to one year post-surgery

• Function - FAAM

  Pre-Operative up to one year post-surgery

Study Arms (1)

All study patients

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

Procedure: Tibiotalocalcaneal Arthrodesis; Device: DynaNail

Interventions

Tibiotalocalcaneal Arthrodesis PROCEDURE

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

All study patients

DynaNail DEVICE

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

All study patients

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:

• 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
• years of age or older

You may not qualify if:

• 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
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Study Officials

• Ashish B Shah, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Dupont, PhD, MS

CONTACT

6782353336; kenneth.dupont@medshape.com

Melanese Leonard-Warren, RN, MSN

CONTACT

2059752671; mnleonard@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: September 23, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)