Avascular Necrosis of the Talus
Conditions
Keywords
Avascular Necrosis, Talus, Ankle
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.
Interventions
DEVICEPatient Specific Talus Spacer
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
Sponsors
Paragon 28
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) | At 5 years compared to Baseline | 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. |
| A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits | 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. | A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle. | 5 Years Post Procedure compared to baseline. | 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. |
Countries
United States
Contacts
CONTACTJacy Legue
CONTACTCaleigh Bates
Outcome results
None listed