ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

University of Virginia

Status and phase: Unknown; Phase 4

Conditions: Ankle Deformity; Ankle Arthritis

Treatments: Device: ViviGen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04138017

20532

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

ViviGen Cellular Bone Matrix

Experimental group

Description:

Patients will receive the vivigen cellular bone matrix

Treatment:

Device: ViviGen