Back to resultsViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis (ViviGen)
Primary Purpose
Ankle Deformity, Ankle Arthritis
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ViviGen
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Deformity focused on measuring Arthrodesis
Eligibility Criteria
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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ViviGen Cellular Bone Matrix
Arm Description
Patients will receive the vivigen cellular bone matrix
Outcomes
Primary Outcome Measures
Fusion
Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%
Secondary Outcome Measures
Failure of hardware or obvious non-union
Failure measured through clinical and radiographic evidence
Foot and Ankle Ability Measure (FAAM)
Patient reported outcome measurement that includes 29-item questionnaire divided into two subscales: 21-item activities of daily living subscale and 8-item sports subscale. Response options are given in 5 point Likert scales (range from 4-0)
Vitamin D levels
25-Hydroxyvitamin D2 and D3 Blood test
Visual Analog Pain Scale
Patient Foot pain reported on a 10 Centimeter line. Patient is asked to draw a vertical line where they believe their pain falls at rest and when active. This is on a scale of 0-10 with 0 being no pain and 10 being the most pain.
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.
VR-12 (Veterans RAND 12)
Patient reported outcome for health related quality of life using a 12 item questionnaire. This is broken into two scores: Physical Health component scores, and Mental Health component scores.
Patient-Reported Outcomes Measurement Information System Physical Function-Short Form 8b (PROMIS Item Bank v2.0-Physical Function -Short Form 8b)
Patient self-reported capability for physical function using 8 questions to assess current function of an adult in the general population.
Full Information
NCT ID
NCT04138017
First Posted
January 2, 2019
Last Updated
February 8, 2022
Sponsor
University of Virginia
Collaborators
DePuy Synthes
1. Study Identification
Unique Protocol Identification Number
NCT04138017
Brief Title
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
Acronym
ViviGen
Official Title
Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
DePuy Synthes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Deformity, Ankle Arthritis
Keywords
Arthrodesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ViviGen Cellular Bone Matrix
Arm Type
Experimental
Arm Description
Patients will receive the vivigen cellular bone matrix
Intervention Type
Device
Intervention Name(s)
ViviGen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fusion
Description
Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Failure of hardware or obvious non-union
Description
Failure measured through clinical and radiographic evidence
Time Frame
12 months
Title
Foot and Ankle Ability Measure (FAAM)
Description
Patient reported outcome measurement that includes 29-item questionnaire divided into two subscales: 21-item activities of daily living subscale and 8-item sports subscale. Response options are given in 5 point Likert scales (range from 4-0)
Time Frame
12 months
Title
Vitamin D levels
Description
25-Hydroxyvitamin D2 and D3 Blood test
Time Frame
6 months
Title
Visual Analog Pain Scale
Description
Patient Foot pain reported on a 10 Centimeter line. Patient is asked to draw a vertical line where they believe their pain falls at rest and when active. This is on a scale of 0-10 with 0 being no pain and 10 being the most pain.
Time Frame
12 months
Title
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
Description
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
12 months
Title
VR-12 (Veterans RAND 12)
Description
Patient reported outcome for health related quality of life using a 12 item questionnaire. This is broken into two scores: Physical Health component scores, and Mental Health component scores.
Time Frame
12 months
Title
Patient-Reported Outcomes Measurement Information System Physical Function-Short Form 8b (PROMIS Item Bank v2.0-Physical Function -Short Form 8b)
Description
Patient self-reported capability for physical function using 8 questions to assess current function of an adult in the general population.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Park, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
We'll reach out to this number within 24 hrs