Recruiting

Talus Spacer

Sponsor:

Paragon 28

Code:

NCT05364606

Conditions

Avascular Necrosis of the Talus

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Patient Specific Talus Spacer

Study Details

Brief summary:

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

Conditions

Avascular Necrosis of the Talus

Study ID

NCT05364606

Start date

Jul 8, 2022

Status verified date

Nov, 2024

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Aug 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

50 Subjects

50 Subjects Receiving the Patient Specific Talus Spacer.

Interventions

Patient Specific Talus Spacer

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

Primary outcome measure

  • Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) [ Time Frame: At 5 years compared to Baseline ]
  • A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits [ Time Frame: 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. ]

Central Contacts and Locations

Locations

Redwood Orthopaedics

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Thomas Chang, DPM

707-544-3400

Principal Investigator:

Thomas Chang, DMP

Fort Wayne Orthopedics

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Faith Etherington, PA-C

260-436-8686

Principal Investigator:

Matthew Beuchel, MD

Mercy Institute for Foot & Ankle Reconstruction

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Maggie Manchester

mmanches@mdmercy.com

Principal Investigator:

Patrick Maloney, MD

Duke Orthopeadics Arringdon

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

Principal Investigator:

Andrew Hanselman, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Josh Morningstar

morninjo@musc.edu

Principal Investigator:

Christoper Gross, MD

UT Physicians Orthopedics - Pearland

Recruiting

Pearland, Texas, United States, 77584

Contacts

Principal Investigator:

Taggart Gauvain, MD

More Information

Sponsor

Paragon 28

Last update posted

Nov 7, 2024

Last verified

Nov, 2024

Keywords

  • Avascular Necrosis
  • Talus
  • Ankle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Paragon 28 on 2024-11-07.