Ankle Arthritis, Ankle Deformity
Conditions
Keywords
Arthrodesis
Brief 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.
Interventions
DEVICEViviGen
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.
Sponsors
DePuy Synthes
University of Virginia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure * Age 18-80 * Willing to complete all follow up evaluations
Exclusion criteria
* 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 * Hemoglobin A1c greater than 8.0% * Tobacco or Nicotine use 6 weeks prior to surgery * BMI greater than 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Union Rates | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure of Hardware or Obvious Non-union | 12 months | Failure measured through clinical and radiographic evidence |
| Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale | baseline, 3 month, 6 month, 1 year | 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. |
| Vitamin D Levels | baseline, 6 months | 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. |
| American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score | baseline, 3 month, 6 month, 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | ViviGen Cellular Bone Matrix | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 62.07 years STANDARD_DEVIATION 7.85 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
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.
Time frame: 12 months
Population: total number of joints assessed for fusion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViviGen Cellular Bone Matrix | Union Rates | 23 joints fused |
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.
Time frame: baseline, 3 month, 6 month, 1 year
Population: 1 subject did not complete 1 year timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViviGen Cellular Bone Matrix | American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score | 1 year | 79.85 score on a scale | Standard Deviation 12.23 |
| ViviGen Cellular Bone Matrix | American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score | baseline | 48.93 score on a scale | Standard Deviation 12.93 |
| ViviGen Cellular Bone Matrix | American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score | 3 month | 64.71 score on a scale | Standard Deviation 13.38 |
| ViviGen Cellular Bone Matrix | American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score | 6 month | 69.43 score on a scale | Standard Deviation 21.86 |
Secondary
Failure of Hardware or Obvious Non-union
Failure measured through clinical and radiographic evidence
Time frame: 12 months
Population: of the 30 joints analyzed in 14 subjects, 7 did not fuse to 50%
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViviGen Cellular Bone Matrix | Failure of Hardware or Obvious Non-union | 7 participants |
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.
Time frame: baseline, 3 month, 6 month, 1 year
Population: 1 subject did not complete the 1 year time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViviGen Cellular Bone Matrix | Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale | baseline | 53.52 Percentage | Standard Deviation 18.94 |
| ViviGen Cellular Bone Matrix | Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale | 3 month | 61.09 Percentage | Standard Deviation 23.76 |
| ViviGen Cellular Bone Matrix | Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale | 6 month | 73.30 Percentage | Standard Deviation 20.86 |
| ViviGen Cellular Bone Matrix | Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale | 1 year | 80.69 Percentage | Standard Deviation 18.69 |
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.
Time frame: baseline, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViviGen Cellular Bone Matrix | Vitamin D Levels | Baseline | 48.17 ng/mL | Standard Deviation 14.99 |
| ViviGen Cellular Bone Matrix | Vitamin D Levels | 6 month | 55.86 ng/mL | Standard Deviation 15 |