ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-23

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ankle Deformity Ankle Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ViviGen Cellular Bone Matrix

Patients will receive the vivigen cellular bone matrix

ViviGen

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No