ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis (ViviGen)
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|ClinicalTrials.gov Identifier: NCT04138017|
Recruitment Status : Enrolling by invitation
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ankle Deformity Ankle Arthritis||Device: ViviGen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: ViviGen Cellular Bone Matrix
Patients will receive the vivigen cellular bone matrix
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.
- Fusion [ Time Frame: 12 months ]Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50%
- Failure of hardware or obvious non-union [ Time Frame: 12 months ]Failure measured through clinical and radiographic evidence
- 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)
- Vitamin D levels [ Time Frame: 6 months ]25-Hydroxyvitamin D2 and D3 Blood test
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04138017
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Joseph Park, MD||University of Virginia|