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Subtalar ArthrodesisEarly Phase 1NCT07884448

PliaFX Flo Subtalar Fusion Study

A Early Phase 1 study testing PliaFX Flo Allograft in people with Subtalar Arthrodesis, run by St. Paul's Hospital, Canada at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Subtalar Arthrodesis
What is being tested?
PliaFX Flo Allograft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
Oct 2026to Dec 2031
Phase
Early Phase 1
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is at least 19 years of age.
  • The subject is considered to be skeletally mature.
  • The subject qualifies for subtalar fusion based on physical examination and/ or past medical history including isolated osteoarthritis, post-traumatic, degenerative, or rheumatoid arthritis of the ankle.
  • The subject experiences severe pain in the subtalar joint that could not be cured with non-operative treatment options.
  • The patient may undergo a subtalar fusion as part of a triple arthrodesis.
  • The patient may have forefoot pathology addressed by either prior or concurrent surgery (osteotomies or fusions).
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  • The patient consented for either an arthroscopic or open procedure.
  • The subject is able to comply with all post-operative evaluations and visits.
  • The subject consents to and will receive either no graft or PliaFX® Flo allograft during their surgery

Who cannot join

  • The subject has:
  • Severe osteoporosis
  • Neuromuscular impairment
  • Prior infection in the affected joint
  • The subject currently has acute infections that, in the opinion of the Investigator, may complicate healing.
  • The subject has a known or suspected allergy to any of the processing reagents listed in the packet insert (alcohol, glycinate buffer, and glycerol).
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  • The subject is renal compromised.
  • The subject has a major risk factor for non-union (ex. poorly controlled diabetes or current smoker).
  • The subject is undergoing a revision of a prior subtalar fusion.
  • The subject has had a prior ankle joint fusion.
  • An ankle joint replacement or ankle joint fusion may be performed during the same sitting.
  • The subject has a BMI of > 50 kg/m2.
  • The subject is known to be pregnant, or plans to become pregnant during the study period
  • The investigator judges the subject to be unable or unlikely to remain compliant to follow-up due to a physical or mental condition (ex. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.).
  • The subject is unable to provide informed consent.
  • The subject is unable to communicate with the research team.
  • The subject is unable to comply with follow-up.
  • The subject has a history of substance addiction (e.g. recreational drugs, narcotics, or alcohol) within 12 months prior to screening for study entry
  • The subject will be receiving a structural autograft or allograft (such as a femoral head graft or tri cortical iliac crest graft) to fill a defect greater than 1cm3

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Biraj Bora contact

604-813-0889

biraj.bora@phc.ca

Canada1 site

  • St. Paul's Hospital

    Vancouver, British Colombia, V6Z 1Y6

    Biraj Bora, 604-813-0889, biraj.bora@phc.ca

Other trials in Canada

About this study

Official title: A Prospective Pilot Comparative Study to Evaluate the Efficacy of PliaFX® Flo Allograft in Subtalar Arthrodesis at St. Paul's Hospital in Vancouver, Canada

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.

Being tested
PliaFX Flo Allograft
Keywords
PliaFX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PliaFX Flo AllograftDevice

    Participant will receive the PliaFX Flo Allograft during their Subtalar Arthrodesis procedure.

Study groups in NCT07884448
Study groupRoleWhat they receive
PliaFX Flo AllograftExperimentalParticipant will receive PliaFX Flo during their Subtalar Arthrodesis procedure.
Receives: Device: PliaFX Flo Allograft
No GraftNo interventionParticipant will receive no graft during their Subtalar Arthrodesis procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Bridging Percentage

    Bone bridging percentage measured by CT scans at 12, 24, and 52 weeks post-operatively.

    Measured: Enrollment to last Follow-up visit (52 weeks)

Secondary outcomes (6)

  1. Foot and Ankle Measure (FAAM) Questionnaire

    Minimum value of 0, maximum value of 100, and lower scores are worse.

    Measured: Enrollment to last follow up visit (52 weeks)

  2. Current Health Assessment Questionnaire

    Minimum value of 0, maximum value of 100, and higher scores are worse.

    Measured: Enrollment to last follow up visit (52 weeks)

  3. American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire

    Minimum value of 0, maximum value of 100, and lower scores are worse.

    Measured: Enrollment to last follow up visit (52 weeks)

  4. Demographics Questionnaire

    Measured: Enrollment to last follow up visit (52 weeks)

  5. Ankle Osteoarthritis Scale

    Minimum value of 1, maximum value of 100, and higher scores are worse.

    Measured: Enrollment to last follow up visit (52 weeks)

  6. SF-36 Health Survey

    Measured: Enrollment to last follow up visit (52 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Model description
One group will receive PliaFX Flo Allograft, one group will receive no graft.
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07884448
Sponsor's protocol ID
H26-01617
Status last verified
Oct 2026
First submitted
5 Oct 2026
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PliaFX Flo Allograft in people with Subtalar Arthrodesis, run by St. Paul's Hospital, Canada at 1 site in Canada.

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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Biraj Bora (604-813-0889, biraj.bora@phc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Bridging Percentage (time frame: Enrollment to last Follow-up visit (52 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07884448.

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 20 Oct 2026.

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