ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04138017
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Virginia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joseph Park, MD
Principal Investigator Affiliation	University of Virginia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ankle Deformity, Ankle Arthritis

Arms & Interventions

Arms

Experimental: ViviGen Cellular Bone Matrix

Patients will receive the vivigen cellular bone matrix

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Virginia, Charlottesville, Virginia

Status

Address

University of Virginia

Charlottesville, Virginia, 22908

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