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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViviGen Cellular Bone Matrix | Patients will receive the vivigen cellular bone matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViviGen | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Failure of Hardware or Obvious Non-union | Failure measured through clinical and radiographic evidence | 12 months |
| Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects participating in this study are receiving Vivigen as part of standard care. They are not assigned to receive Vivigen as part of study.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Park, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ViviGen Cellular Bone Matrix | Patients will receive the vivigen cellular bone matrix ViviGen: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ViviGen Cellular Bone Matrix | Patients will receive the vivigen cellular bone matrix ViviGen: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | total number of joints assessed for fusion. | Posted | Number | joints fused | 12 months | joints | joints |
|
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ViviGen Cellular Bone Matrix | Patients will receive the vivigen cellular bone matrix ViviGen: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision surgery of Triple Arthrodesis, hardware removal | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ankle synovitis / impingement | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric McVey, Clinical Research Coordinator | University of Virginia | 434.243.5382 | eric.mcvey@uvahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2021 | May 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
| 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. | 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. | baseline, 3 month, 6 month, 1 year |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| joints |
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| Secondary | Failure of Hardware or Obvious Non-union | Failure measured through clinical and radiographic evidence | of the 30 joints analyzed in 14 subjects, 7 did not fuse to 50% | Posted | Number | participants | 12 months | joints | joints |
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| Secondary | 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. | 1 subject did not complete the 1 year time point. | Posted | Mean | Standard Deviation | Percentage | baseline, 3 month, 6 month, 1 year |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | baseline, 6 months |
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| Secondary | 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. | 1 subject did not complete 1 year timepoint. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month, 6 month, 1 year |
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| 0 |
| 15 |
| 1 |
| 15 |
| 1 |
| 15 |
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| 6 month |
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| 1 year |
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| 6 month |
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| 1 year |
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