The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

NCT04831645 | Unknown FDA Device

• 1 other identifier: MedShape011221
• Study Type: observational
• Target: 45
• 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 utilizing longitudinal weight-bearing computed tomographic imaging. Of particular focus will be assessment of compressive element recovery and its relation to fusion development over time and weight-bearing status. Additionally, the study will incorporate longitudinal fusion assessment to evaluate differences between three-dimensional weight-bearing computed tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the fusion process. Finally, the study will evaluate the differences in WBCT-based fusion assessment between automated and manual methodologies for fusion area calculation.

Conditions

Ankle Arthritis; Arthritis Foot

Keywords

Subtalar Arthrodesis; Intramedullary Nail; Ankle Arthrodesis; Internal Fixation; Sustained Compression; Longitudinal Computed Tomography; Tibiotalar Arthrodesis; Joint Fusion

Outcome Measures

Primary Outcomes (1)

• Fusion

  Joint Fusion, as measured by radiographs and CT scans. Fusion rates will be assessed based on varying CT fusion areas. Fusion rates based on X-Ray vs CT assessment will also be compared. CT fusion rates based on varying fusion areas will be compared with PROM data to assess which fusion area actually corresponds to increased function and reduced pain.

  Pre-Operative to 1 year post-surgery

Secondary Outcomes (6)

• VAS

  Pre-Operative up to one year post-surgery

• VR-12

  Pre-Operative up to one year post-surgery

• FFI-R

  Pre-Operative up to one year post-surgery

• FAAM

  Pre-Operative up to one year post-surgery

• AOS

  Pre-Operative up to one year post-surgery

Other Outcomes (1)

• Automated vs Manual Fusion Assessment

  Up to one year post-surgery

Interventions

DynaNail DEVICE

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Tibiotalocalcaneal Arthrodesis PROCEDURE

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

Also known as: Subtalar Arthrodesis, Tibiotalar Arthrodesis

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 of the Orthopedic Foot and Ankle Center with end-stage tibiotalar (ankle) and talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study. In general, tibiotalar and subtalar arthritis is caused by trauma. Traumatic injuries have no predilection for race, religion, cultural background, etc. Therefore, all demographic groups will have access to this study and should be represented.

You may qualify if:

• Meets indications for TTC arthrodesis and receives the DynaNail implant
• Able to understand the requirements of the study
• Willing to comply with the study protocol
• Sign an Informed consent
• 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
• CurveBeam LLC: collaborator
• Orthopedic Foot and Ankle Center, Ohio: collaborator

Study Sites (1)

Orthopedic Foot and Ankle Center

Worthington, Ohio, 43085, United States

RECRUITING

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Gregory C Berlet, MD

  Orthopedic Foot and Ankle Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth M Dupont, Ph.D.

CONTACT

6782353336; Kenneth.dupont@medshape.com

Antonio Malloy-McCoy, MPH

CONTACT

614-895-8747; mccoyam@orthofootankle.com

Study Design

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

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: May 24, 2021
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: May 25, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)