An Early Phase 1 interventional study of PliaFX Flo Allograft in Subtalar Arthrodesis, sponsored by St. Paul's Hospital, Canada. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by St. Paul's Hospital, Canada · Early Phase 1, Interventional, and Device feasibility
During a subtalar fusion, the bones making up the subtalar joint (talus and calcaneus) are permanently fused together. In the procedure, any damaged cartilage and bone at the subtalar joint is removed, then screws are inserted into the joint to fuse the bones together. Depending on the surgeon, a bone graft is sometimes applied between the bones prior to screw insertion to aid in bone bridging (growth of bone into the fusion site). Participants who consent to this study and are assigned to the PliaFX® Flo Allograft group, will receive PliaFX® Flo Allograft (human tissue donated from a donor) at the fusion site. The PliaFX® Flo system is demineralized bone fibers (hard minerals removed from bone using acid) in a sterile syringe that allows for delivery into small areas where bone graft is needed to assist bone fusion. The allograft bone fibers are produced from donated human cadaver (deceased human) bone.
This study aims to determine whether the use of PliaFX® Flo Allograft in subtalar fusions will improve functioning and healing of the bone and cartilage for patients like you. Participants who are interested will discuss with their surgeon and be randomly assigned to one of the two study procedures below. The patient will not know what group they are in until after all data has been collected and all study visits are complete.
St. Paul's Hospital, Canada is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
The subject has:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Participant will receive PliaFX Flo during their Subtalar Arthrodesis procedure.
Device: PliaFX Flo Allograft
Participant will receive no graft during their Subtalar Arthrodesis procedure.
Participant will receive the PliaFX Flo Allograft during their Subtalar Arthrodesis procedure.
Bone Bridging Percentage
Bone bridging percentage measured by CT scans at 12, 24, and 52 weeks post-operatively.
Time frame: Enrollment to last Follow-up visit (52 weeks)
Foot and Ankle Measure (FAAM) Questionnaire
Minimum value of 0, maximum value of 100, and lower scores are worse.
Time frame: Enrollment to last follow up visit (52 weeks)
Current Health Assessment Questionnaire
Minimum value of 0, maximum value of 100, and higher scores are worse.
Time frame: Enrollment to last follow up visit (52 weeks)
American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire
Minimum value of 0, maximum value of 100, and lower scores are worse.
Time frame: Enrollment to last follow up visit (52 weeks)
Demographics Questionnaire
Time frame: Enrollment to last follow up visit (52 weeks)
Ankle Osteoarthritis Scale
Minimum value of 1, maximum value of 100, and higher scores are worse.
Time frame: Enrollment to last follow up visit (52 weeks)
SF-36 Health Survey
Time frame: Enrollment to last follow up visit (52 weeks)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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St. Paul's Hospital, Canada