Patient Specific Talus Spacer Post Approval Study

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

Study Overview

• Status: Recruiting
• Conditions: Avascular Necrosis of the Talus
• Intervention / Treatment: Device: Patient Specific Talus Spacer

Detailed Description

This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ralph Busoye; Phone Number: 720-399-3400; Email: rbusoye@paragon28.com

Study Locations

• United States
  • California
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Redwood Orthopaedics
      • Contact: Thomas Chang, DPM; Phone Number: 707-544-3400
      • Principal Investigator: Thomas Chang, DMP
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Orthopedics
      • Contact: Faith Etherington, PA-C; Phone Number: 260-436-8686
      • Principal Investigator: Matthew Beuchel, MD
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Mercy Institute for Foot & Ankle Reconstruction
      • Contact: Maggie Manchester; Email: mmanches@mdmercy.com
      • Principal Investigator: Patrick Maloney, MD
      • Sub-Investigator: Clifford Jeng, MD
      • Sub-Investigator: Lew Schon, MD
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Recruiting
      • Duke Orthopeadics Arringdon
      • Contact: Kalynn Purnell; Phone Number: 919-681-6035; Email: kalyn.purnell@duke.edu
      • Principal Investigator: Andrew Hanselman, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Josh Morningstar; Email: morninjo@musc.edu
      • Principal Investigator: Christoper Gross, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Avascular Necrosis of the Ankle Joint.

Description

Inclusion Criteria:

1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
2. Avascular necrosis of the ankle joint;
3. Age 21 years old or older;
4. Subject has good general health; and
5. Subject signs a written informed consent form (ICF) prior to the surgical procedure.

Exclusion Criteria:

1. Presence of any contraindication identified in the device Instructions for Use;
2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
4. For female subjects, pregnancy;
5. Active systemic disease, such as AIDS, HIV, or active infection;
6. Active infection or the skin is compromised at the surgical site; and
7. Systemic disease that would affect the subject's welfare;
8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up.
10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient.
11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
50 Subjects; 50 Subjects Receiving the Patient Specific Talus Spacer.	Device: Patient Specific Talus Spacer; Patient Specific Talus Spacer is a solid polished replica of the patient's bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)	Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.	At 5 years compared to Baseline
A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits	A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative	A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.	Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on ankle range of motion (ROM) as assessed by the surgeon at each follow up visit through 5 years Post Operative.	5 Years Post Procedure compared to baseline.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Analyses at 5 Years Post Operative compared to Baseline for Foot and Outcome Score FAOS	Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on Foot and Ankle Outcome Score (FAOS - which include Pain, Other Symptoms, Sport and Recreation Function, Activities of Daily Living (ADL) and Foot and Ankle related Quality of Life (QOL). This is a series of questions for each sub section that the subject will answer at the subjects visits.	5 Years Post Procedure compared to baseline

Collaborators and Investigators

• Sponsor: Paragon 28
• Investigators: Study Director: Laura Brinker, DPM, Paragon 28, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2022
• Primary Completion (ANTICIPATED): August 30, 2029
• Study Completion (ANTICIPATED): November 30, 2029

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (ACTUAL): May 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Ankle; Avascular Necrosis; Talus
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: AOPSTSPAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After study completion and data analysis, results of the study will be shared with the Investigator's who participated. Individual Patient Identifiers will not be provided. Only specific numbers from the statistical analysis will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No