Avascular Necrosis of the TalusNCT05364606
Patient Specific Talus Spacer Post Approval Study
An observational study of Avascular Necrosis of the Talus, run by Paragon 28 at 5 sites in United States.
Trial summary
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Avascular Necrosis of the Talus
- What is being tested?
- Patient Specific Talus Spacer
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jul 2022to 30 Nov 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Avascular Necrosis of the Ankle Joint.
Who may be able to join
- Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
- Avascular necrosis of the ankle joint;
- Age 21 years old or older;
- Subject has good general health; and
- Subject signs a written informed consent form (ICF) prior to the surgical procedure.
Who cannot join
- Presence of any contraindication identified in the device Instructions for Use;
- Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
- Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
- For female subjects, pregnancy;
- Active systemic disease, such as AIDS, HIV, or active infection;
- Active infection or the skin is compromised at the surgical site; and
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- Systemic disease that would affect the subject's welfare;
- Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
- 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.
- 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.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Mercy Institute for Foot & Ankle Reconstruction
Baltimore, Maryland, 21202
Katherine Convery, 410.332.9035, kconvery@mdmercy.com
Patrick Maloney, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Hana Hashioka, hashiokah@musc.edu
Christoper Gross, MD
- Recruiting
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804
Faith Etherington, PA-C, 260-436-8686
Matthew Beuchel, MD
- Recruiting
UT Physicians Orthopedics - Pearland
Pearland, Texas, 77584
Jordan Harmon, 713-962-9954, jordan.j.harmon@uth.tmc.edu
Taggart Gauvain, MD
- Recruiting
Sutter Health Santa Rosa
Santa Rosa, California, 95403
Thomas Chang, DPM, 707-544-3400
Thomas Chang, DMP
About this study
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Read the 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.
- Conditions
- Avascular Necrosis of the Talus
- Being tested
- Patient Specific Talus Spacer
- Keywords
- Avascular Necrosis, Talus, Ankle
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific Talus SpacerDevice
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
| Study group | Role | What they receive |
|---|---|---|
| 50 Subjects | 50 Subjects Receiving the Patient Specific Talus Spacer. Receives: Device: Patient Specific Talus Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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 (1)
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.
Measured: 5 Years Post Procedure compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start8 Jul 2022
- Primary completion30 Aug 2033 (estimated)
- Study completion30 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of the TalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paragon 28
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364606
- Sponsor's protocol ID
- AOPSTSPAS
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Talus Spacer Post Approval Study
- ClinicalTrials.gov ID
- NCT05364606
- Acronym / sponsor ID
- AOPSTSPAS
- Conditions
- Avascular Necrosis of the Talus
- Keywords
- Avascular Necrosis, Talus, Ankle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 30 Aug 2033 (estimated)
- Study completion
- 30 Nov 2033 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 Subjects | – | Device: Patient Specific Talus Spacer50 Subjects Receiving the Patient Specific Talus Spacer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Avascular Necrosis of the Ankle Joint.
Key inclusion criteria (5 listed)
- Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
- Avascular necrosis of the ankle joint;
- Age 21 years old or older;
- Subject has good general health; and
- Subject signs a written informed consent form (ICF) prior to the surgical procedure.
Key exclusion criteria (11 listed)
- Presence of any contraindication identified in the device Instructions for Use;
- Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
- Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
- For female subjects, pregnancy;
- Active systemic disease, such as AIDS, HIV, or active infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Specific Talus SpacerPatient Specific Talus Spacer is a solid polished replica of the patient's bone. | Device | 50 Subjects |
Primary outcome
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
Time frame: 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
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.
A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative
1 secondary outcome
Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.
Time frame: 5 Years Post Procedure compared to baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Avascular Necrosis of the Talus
RecruitingObservational study
Talus Replacement Registry
Avascular Necrosis of the Talus
Enrolling by invitationObservational study
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis of the Talus, run by Paragon 28 at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacy Legue (720-399-3400, jlegue@paragon28.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) (time frame: At 5 years compared to Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.