Trial Outcomes & Findings for ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis (NCT NCT04138017)

NCT ID: NCT04138017

Last Updated: 2025-06-19

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-06-19

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ViviGen Cellular Bone Matrix n=15 Participants 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.
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=15 Participants
Age, Categorical >=65 years	6 Participants n=15 Participants
Age, Continuous	62.07 years STANDARD_DEVIATION 7.85 • n=15 Participants
Sex: Female, Male Female	12 Participants n=15 Participants
Sex: Female, Male Male	3 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: 12 months

Population: total number of joints assessed for fusion.

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.

Outcome measures

Measure	ViviGen Cellular Bone Matrix n=30 joints 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.
Union Rates	23 joints fused

SECONDARY outcome

Timeframe: 12 months

Population: of the 30 joints analyzed in 14 subjects, 7 did not fuse to 50%

Failure measured through clinical and radiographic evidence

Outcome measures

Measure	ViviGen Cellular Bone Matrix n=30 joints 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.
Failure of Hardware or Obvious Non-union	7 participants

SECONDARY outcome

Timeframe: baseline, 3 month, 6 month, 1 year

Population: 1 subject did not complete the 1 year time point.

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.

Outcome measures

Measure	ViviGen Cellular Bone Matrix n=14 Participants 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.
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale baseline	53.52 Percentage Standard Deviation 18.94
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale 3 month	61.09 Percentage Standard Deviation 23.76
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale 6 month	73.30 Percentage Standard Deviation 20.86
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale 1 year	80.69 Percentage Standard Deviation 18.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ViviGen Cellular Bone Matrix n=14 Participants 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.
Vitamin D Levels Baseline	48.17 ng/mL Standard Deviation 14.99
Vitamin D Levels 6 month	55.86 ng/mL Standard Deviation 15.00

SECONDARY outcome

Timeframe: baseline, 3 month, 6 month, 1 year

Population: 1 subject did not complete 1 year timepoint.

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.

Outcome measures

Measure	ViviGen Cellular Bone Matrix n=14 Participants 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.
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score baseline	48.93 score on a scale Standard Deviation 12.93
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score 3 month	64.71 score on a scale Standard Deviation 13.38
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score 6 month	69.43 score on a scale Standard Deviation 21.86
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score 1 year	79.85 score on a scale Standard Deviation 12.23

Adverse Events

ViviGen Cellular Bone Matrix

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	ViviGen Cellular Bone Matrix n=15 participants at risk 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.
Surgical and medical procedures Revision surgery of Triple Arthrodesis, hardware removal	6.7% 1/15 • Number of events 1 • 1 year.

Other adverse events

Measure	ViviGen Cellular Bone Matrix n=15 participants at risk 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.
Surgical and medical procedures Left ankle synovitis / impingement	6.7% 1/15 • Number of events 1 • 1 year.

Additional Information

Eric McVey, Clinical Research Coordinator

University of Virginia

Phone: 434.243.5382

Email: eric.mcvey@uvahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place