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Cellular Bone Matrix
ViviGen for Ankle Arthritis (ViviGen Trial)
Phase 4
Waitlist Available
Led By Joseph Park, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ViviGen Trial Summary
This trial is testing a new bone graft material to see if it works well for people who need surgery to fuse their heel bones.
Who is the study for?
This trial is for adults aged 18-80 who need a hindfoot ankle arthrodesis procedure and can follow up with evaluations. It's not for those with high blood sugar levels, large bone defects, weak bones, previous foot fusion or infection at the surgery site, inability to stay off the foot after surgery, vitamin D deficiency, recent tobacco use, or a BMI over 40.Check my eligibility
What is being tested?
The study tests ViviGen Cellular Bone Matrix in patients undergoing hindfoot or ankle fusion surgery. The goal is to see if ViviGen helps bones fuse together as an alternative to using the patient's own bone tissue (autograft).See study design
What are the potential side effects?
While specific side effects of ViviGen are not listed here, similar treatments may cause local reactions at the graft site like pain or swelling and could potentially lead to complications in bone healing.
ViviGen Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fusion
Secondary outcome measures
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
Failure of hardware or obvious non-union
Ankle
+4 moreViviGen Trial Design
1Treatment groups
Experimental Treatment
Group I: ViviGen Cellular Bone MatrixExperimental Treatment1 Intervention
Patients will receive the vivigen cellular bone matrix
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ViviGen
2016
N/A
~100
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,016 Total Patients Enrolled
DePuy SynthesIndustry Sponsor
30 Previous Clinical Trials
4,909 Total Patients Enrolled
Joseph Park, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You recently had surgery on one of your ankles to permanently fuse the joint.You have a bone defect that requires more than 10 cubic centimeters of bone graft material.Your bones are not strong enough to be fixed in place during the study.You had an infection in the area where the fusion surgery is planned.You are unable to avoid putting weight on a specific body part.You have had a surgery called arthrodesis before.You haven't used any tobacco or nicotine products for 6 weeks before the surgery.You are severely overweight with a BMI over 40.
Research Study Groups:
This trial has the following groups:- Group 1: ViviGen Cellular Bone Matrix
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators currently seeking participants for this trial?
"Clinicaltrials.gov information confirms that this particular medical trial, which was first published on October 23rd 2018, is no longer actively recruiting patients at this time. However, other trials are currently enlisting participants with 474 openings accessible right now."
Answered by AI
Could you elucidate the potential risks of using ViviGen?
"Our team has assessed ViviGen's safety to be a 3, as this treatment is approved and currently in its final phase of clinical trials."
Answered by AI
Are participants under the age of 35 eligible to join this experiment?
"With regards to the requirements for enrolment, this clinical trial has a floor of 18 years old and an upper limit of 80."
Answered by AI
Am I qualified to participate in this research endeavor?
"To be eligible to join this study, a patient must suffer from arthritis and fall within the age bracket of 18-80. Currently, 15 individuals are being sought for recruitment."
Answered by AI
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