The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

NCT02324907 | Completed

• 1 other identifier: Pro00055335
• Study Type: observational
• Target: 39
• 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

Outcome Measures

Primary Outcomes (4)

• Change in Pain Assessment

  Visual Analog Scale (VAS)

  Pre-operative up to 2 years post surgery

• Change in Functional Assessment

  Short Form 36 (SF-36)

  Pre-operative up to 2 years post surgery

• Change in Functional Assessment

  Foot and Ankle Ability Measure (FAAM)

  Pre-operative up to 2 years post surgery

• Fusion, as measured by radiograph and CT scan

  radiographs taken Pre-operatively, 2 weeks, 4 weeks, 6 weeks, 3 Months, 6 Months, 12 Months and 24 Months. A CT scan will be done standard of care at 6 months.

  Pre-operative up to 2 years post surgery

Study Arms (1)

Tibiotalocalcaneal arthrodesis with DynaNail

Procedure/Surgery: Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail

Device: Procedure/Surgery

Interventions

Procedure/Surgery DEVICE

Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.

Tibiotalocalcaneal arthrodesis with DynaNail

Eligibility Criteria

• Age: 18 Years - 95 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 over age 18 who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the only exclusion criteria will be 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:

• Over the age of 18
• Ankle and Subtalar arthritis
• Failed non-operative management

You may not qualify if:

• Patients who do not meet the minimum age of 18 years.

Sponsors & Collaborators

• Duke University: lead
• MedShape, Inc: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Mark Easley, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 24, 2014
• Study Start: January 28, 2015
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: January 11, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)