Ankle DeformityViviGenNCT04138017
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
An observational study of Ankle Deformity and Ankle Arthritis, run by University of Virginia at 1 site in United States.
Trial summary
To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Deformity, Ankle Arthritis
- What is being tested?
- ViviGen
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 1 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects participating in this study are receiving Vivigen as part of standard care. They are not assigned to receive Vivigen as part of study.
Who may be able to join
- Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
- Age 18-80
- Willing to complete all follow up evaluations
Who cannot join
- Prior infection at site of planned arthrodesis
- Prior arthrodesis procedure
- Inability to maintain non-weight bearing status
- Bone defect requiring more than 10 cc of bone graft material
- Known Vitamin D deficiency with a Vitamin D level of <30ng/ml 1 week prior to surgery
- Inadequate bone stock to allow for rigid internal fixation
Show all 9Show fewer
- Hemoglobin A1c greater than 8.0%
- Tobacco or Nicotine use 6 weeks prior to surgery
- BMI greater than 40
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.
- Conditions
- Ankle Deformity, Ankle Arthritis
- Being tested
- ViviGen
- Keywords
- Arthrodesis
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViviGenDevice
A cellular bone matrix which includes viable osteoblasts within a corticocancellous and demineralized bone carrier, represents a unique alternative to autograft or existing products which utilize mesenchymal stem cells.
| Study group | Role | What they receive |
|---|---|---|
| ViviGen Cellular Bone Matrix | Patients will receive the vivigen cellular bone matrix Receives: Device: ViviGen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union Rates
Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%. Results are for total number of joints fused which exceeds the number of participants due to some subjects having multiple joints fused.
Measured: 12 months
Secondary outcomes (4)
Failure of Hardware or Obvious Non-union
Failure measured through clinical and radiographic evidence
Measured: 12 months
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale
For this study, the researchers only utilized the ADL subscale. This patient-reported outcome measure is a 21-item questionnaire assessing fundamental mobility and daily activities. Responses use a 5-point Likert scale ranging from 4 (no difficulty) to 0 (unable to do), with N/A responses excluded. The responses are summed, and the total possible score is calculated by multiplying the number of answered items by 4 (maximum score: 84). The total score is divided by the highest potential score, then multiplied by 100 to yield a percentage. Higher percentages indicate greater physical function, with 100% representing no functional limitations, on the ADL subscale.
Measured: baseline, 3 month, 6 month, 1 year
Vitamin D Levels
25-Hydroxyvitamin D is the primary circulating form of vitamin D and is the most commonly used measure to assess vitamin D status in the blood. The reference range for 25-hydroxy vitamin D test is 20-80 ng/mL. A low test level would indicate lower concentrations of Vitamin D.
Measured: baseline, 6 months
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score
Patient reported outcome for a standardized evaluation of clinical status of ankle- hindfoot. Patient reports their pain and the physician records physical assessment of alignment. Finally function is reported and the AOFAS score ranged from 0-100 with 100 being healthy ankles.
Measured: baseline, 3 month, 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start23 Oct 2018
- Primary completion10 Apr 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle DeformityStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Principal investigator, Joseph Park, University of Virginia
- Investigators
- Joseph Park, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138017
- Sponsor's protocol ID
- 20532
- Acronym
- ViviGen
- Status last verified
- Jun 2025
- First submitted
- 2 Jan 2019
- Last updated
- 19 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
- ClinicalTrials.gov ID
- NCT04138017
- Acronym / sponsor ID
- ViviGen / 20532
- Conditions
- Ankle Deformity, Ankle Arthritis
- Keywords
- Arthrodesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Posted 19 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ViviGen Cellular Bone Matrix | – | Device: ViviGenPatients will receive the vivigen cellular bone matrix |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in this study are receiving Vivigen as part of standard care. They are not assigned to receive Vivigen as part of study.
Key inclusion criteria (3 listed)
- Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
- Age 18-80
- Willing to complete all follow up evaluations
Key exclusion criteria (9 listed)
- Prior infection at site of planned arthrodesis
- Prior arthrodesis procedure
- Inability to maintain non-weight bearing status
- Bone defect requiring more than 10 cc of bone graft material
- Known Vitamin D deficiency with a Vitamin D level of <30ng/ml 1 week prior to surgery
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 |
|---|---|---|
| ViviGenA cellular bone matrix which includes viable osteoblasts within a corticocancellous and demineralized bone carrier, represents a unique alternative to autograft or existing products which utilize mesenchymal stem cells. | Device | ViviGen Cellular Bone Matrix |
Primary outcome
Union Rates
Time frame: 12 months
Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%. Results are for total number of joints fused which exceeds the number of participants due to some subjects having multiple joints fused.
4 secondary outcomes
Failure of Hardware or Obvious Non-union
Time frame: 12 months
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale
Time frame: baseline, 3 month, 6 month, 1 year
Vitamin D Levels
Time frame: baseline, 6 months
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score
Time frame: baseline, 3 month, 6 month, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Joseph Park, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Deformity and Ankle Arthritis, run by University of Virginia at 1 site 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 19 Jun 2025. 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 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?
Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Union Rates (time frame: 12 months). 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 19 Jun 2025.