Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis

NCT04784156 | Unknown FDA Device

• 1 other identifier: Pro00104048
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fusion

  Joint Fusion, as measured by radiograph and CT scan

  From surgery up to one year post-surgery

Secondary Outcomes (5)

• VAS

  Pre-Operative up to one year post-surgery

• Veterans RAND 12 Item Health Survey (VR-12)

  Pre-Operative up to one year post-surgery

• Revised FFI-R

  Pre-Operative up to one year post-surgery

• Foot and Ankle Ability Measure (FAAM)

  Pre-Operative up to one year post-surgery

• American Orthopaedic Foot and Ankle Society Scales (AOFAS)

  Pre-Operative up to one year post-surgery

Study Arms (1)

All study patients

All study patients will be in one group. Interventions: Procedure: Subtalar (Talocalcaneal) arthrodesis Device: DynaNail Mini

Procedure: Subtalar (Talocalcaneal) Arthrodesis; Device: DynaNail Mini

Interventions

Subtalar (Talocalcaneal) Arthrodesis PROCEDURE

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

All study patients

DynaNail Mini DEVICE

Utilization of a novel sustained 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. Patients will be screened for eligibility by the research coordinator/ key personnel in close coordination with the surgeon. Patients at institute with end-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study. Frequently, 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. Approximately 60 patients will be recruited for the study.

You may qualify if:

• 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
• 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
• Pregnant women

Sponsors & Collaborators

• MedShape, Inc: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Arthrodesis

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Christopher Gross, MD

  ASSOCIATE PROFESSOR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Dupont, Ph.D.

CONTACT

6782353336; Kenneth.dupont@medshape.com

Caroline Hoch

CONTACT

9193897136; hoch@musc.edu

Study Design

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

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)