Clinical trial NCT05364606: Patient Specific Talus Spacer Post Approval Study
Official title: Patient Specific Talus Spacer Post Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Avascular Necrosis of the Talus
Keywords: Avascular Necrosis
Talus
Ankle
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Avascular Necrosis of the Ankle Joint.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
timeFrame: At 5 years compared to Baseline
measure: A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
timeFrame: 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 outcomes:
measure: Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.
timeFrame: 5 Years Post Procedure compared to baseline.
Other outcomes:
measure: Additional Analyses at 5 Years Post Operative compared to Baseline for Foot and Outcome Score FAOS
timeFrame: 5 Years Post Procedure compared to baseline
Locations:
city: Santa Rosa
country: United States
facility: Redwood Orthopaedics
state: California
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopedics
state: Indiana
city: Baltimore
country: United States
facility: Mercy Institute for Foot & Ankle Reconstruction
state: Maryland
city: Morrisville
country: United States
facility: Duke Orthopeadics Arringdon
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Pearland
country: United States
facility: UT Physicians Orthopedics - Pearland
state: Texas
Study officials:
References: