ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis (ViviGen)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ankle Deformity; Ankle Arthritis
• Intervention / Treatment: Device: ViviGen

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ViviGen Cellular Bone Matrix; Patients will receive the vivigen cellular bone matrix	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%	12 months

Secondary Outcome Measures

Outcome Measure	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)	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)	12 months
Vitamin D levels	25-Hydroxyvitamin D2 and D3 Blood test	6 months
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.	12 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.	12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Joseph Park, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Arthrodesis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Congenital Abnormalities
• Other Study ID Numbers: 20532

Drug and device information, study documents

• 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