ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

NCT04138017 | Completed Results FDA Device

• 1 other identifier: 20532
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Deformity; Ankle Arthritis

Keywords

Arthrodesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Failure of Hardware or Obvious Non-union

  12 months

• Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale

  baseline, 3 month, 6 month, 1 year

• Vitamin D Levels

  baseline, 6 months

• American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score

  baseline, 3 month, 6 month, 1 year

Study Arms (1)

ViviGen Cellular Bone Matrix

Patients will receive the vivigen cellular bone matrix

Device: ViviGen

Interventions

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.

ViviGen Cellular Bone Matrix

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects participating in this study are receiving Vivigen as part of standard care. They are not assigned to receive Vivigen as part of study.

You may qualify if:

• Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
• Age 18-80
• Willing to complete all follow up evaluations

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• DePuy Synthes: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Eric McVey, Clinical Research Coordinator
• Organization: University of Virginia

eric.mcvey@uvahealth.org

434.243.5382

Study Officials

• Joseph Park, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: October 24, 2019
• Study Start: October 23, 2018
• Primary Completion: April 10, 2023
• Study Completion: December 1, 2023
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Locations

US (1)