Patient Specific Talus Spacer Post Approval Study

Avascular Necrosis of the Talus Clinical Trial

Official title:

Patient Specific Talus Spacer Post Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364606
• Other study ID #: AOPSTSPAS
• Status: Recruiting
• Start date: July 8, 2022
• Est. completion date: November 30, 2029

Study information

• Verified date: November 2023
• Source: Paragon 28
• Contact: Jacy Legue
• Phone: 720-399-3400
• Email: jlegue[@]paragon28.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2029
• Est. primary completion date: August 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of the Talus
• Necrosis

Intervention

Device:
• Patient Specific Talus Spacer
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.

Locations

Country	Name	City	State
United States	Mercy Institute for Foot & Ankle Reconstruction	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Fort Wayne Orthopedics	Fort Wayne	Indiana
United States	Duke Orthopeadics Arringdon	Morrisville	North Carolina
United States	UT Physicians Orthopedics - Pearland	Pearland	Texas
United States	Redwood Orthopaedics	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Paragon 28

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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.