ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Study Overview
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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.

Official Title
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Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis

Conditions
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Ankle Deformity, Ankle Arthritis

Intervention / Treatment
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* Device: ViviGen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ViviGen Cellular Bone Matrix<br>Patients will receive the vivigen cellular bone matrix | Device: ViviGen<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthrodesis