An observational study in Avascular Necrosis of the Talus, sponsored by Paragon 28. Recruiting at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Paragon 28 (part of Zimmer Biomet) · Observational
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 50 is below the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Paragon 28 is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
First submitted before Paragon 28 became part of Zimmer Biomet.
Counted across the registry records on this site, refreshed daily.
Patients with Avascular Necrosis of the Ankle Joint.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 Subjects Receiving the Patient Specific Talus Spacer.
Device: Patient Specific Talus Spacer
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
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.
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
A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative
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.
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.
Time frame: 5 Years Post Procedure compared to baseline.
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.
Time frame: 5 Years Post Procedure compared to baseline
Plan to share: 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.
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Aug 2033, 133 months after the start.
Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's planned 133 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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