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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04138017
Recruitment Status : Unknown
Verified October 2019 by University of Virginia.
Recruitment status was:  Enrolling by invitation
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
DePuy Synthes
Information provided by (Responsible Party):
University of Virginia

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.

Condition or disease Intervention/treatment Phase
Ankle Deformity Ankle Arthritis Device: ViviGen Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.

Primary Outcome Measures :
  1. Fusion [ Time Frame: 12 months ]
    Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%

Secondary Outcome Measures :
  1. Failure of hardware or obvious non-union [ Time Frame: 12 months ]
    Failure measured through clinical and radiographic evidence

  2. Foot and Ankle Ability Measure (FAAM) [ Time Frame: 12 months ]
    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)

  3. Vitamin D levels [ Time Frame: 6 months ]
    25-Hydroxyvitamin D2 and D3 Blood test

  4. Visual Analog Pain Scale [ Time Frame: 12 months ]
    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.

  5. American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score [ Time Frame: 12 months ]
    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.

  6. VR-12 (Veterans RAND 12) [ Time Frame: 12 months ]
    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.

  7. Patient-Reported Outcomes Measurement Information System Physical Function-Short Form 8b (PROMIS Item Bank v2.0-Physical Function -Short Form 8b) [ Time Frame: 12 months ]
    Patient self-reported capability for physical function using 8 questions to assess current function of an adult in the general population.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04138017

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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
DePuy Synthes
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Principal Investigator: Joseph Park, MD University of Virginia
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Responsible Party: University of Virginia Identifier: NCT04138017    
Other Study ID Numbers: 20532
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

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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
Keywords provided by University of Virginia:
Additional relevant MeSH terms:
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Congenital Abnormalities