Fractures, BoneNCT04299022
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
An observational study of Fractures, Bone and Nonunion of Fracture, run by LifeNet Health at 4 sites in United States.
Trial summary
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fractures, Bone, Nonunion of Fracture, Fractures, Open
- What is being tested?
- Vivigen Cellular Bone Matrix
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2021to 31 Jul 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Prospective data will be collected for up to 250 subjects across up to 7 academic medical centers that will receive Vivigen Cellular Bone Matrix for treatment of a fracture. Retrospective data will be collected for up to an additional 250 subjects that received a bone graft adjunct for treatment of a fracture.
Prospective Cohort Inclusion Criteria:
- Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.
Retrospective Cohort Inclusion Criteria:
- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.
Prospective Cohort Exclusion Criteria:
- Patients unable to understand either an English or Spanish consent will be excluded.
- Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 2 recruiting
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
RWJBarnabas Health
Jersey City, New Jersey, 07302
Ian Hong, MD candidate, 914-671-7325, ian.hong@rwjbh.org
Richard Yoon, MD
- Completed
Sentara Hospitals
Norfolk, Virginia, 23507
- Recruiting
OrlandoHealth
Orlando, Florida, 32806
David Krol, david.krol@orlandohealth.com
M. Kareem Shaath, MD
About this study
Official title: Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
Read the detailed description
The prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited, Fracture, Tibial, Fracture of Femur
- Being tested
- Vivigen Cellular Bone Matrix
- Keywords
- fracture, nonunion, allograft
- Medical subject headings
- Fractures, Bone, Fractures, Ununited, Fractures, Open, Tibial Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivigen Cellular Bone MatrixOther
Allograft bone matrix
| Study group | Role | What they receive |
|---|---|---|
| Prospective Registry | Treatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix Receives: Other: Vivigen Cellular Bone Matrix | |
| Retrospective Data Collection | Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintervention Rate
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
Measured: 24 months
Secondary outcomes (2)
Fusion Rate
Acute fracture, delayed union or nonunion rate as assessed with radiographs at 6 weeks, 3 months, 6 months, 12 months and 24 months
Measured: 24 months
Patient Reported Outcome Measurement Information System (PROMIS) Scores
Patient reported outcome measures will be measured via PROMIS scoring tool (mental and physical). The PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jun 2021
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Dorsch, Study director, LifeNet Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299022
- Sponsor's protocol ID
- CR-20-002
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2020
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
- ClinicalTrials.gov ID
- NCT04299022
- Acronym / sponsor ID
- CR-20-002
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited, Fracture, Tibial, Fracture of Femur
- Keywords
- fracture, nonunion, allograft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
Detailed description
The prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Registry | – | Other: Vivigen Cellular Bone MatrixTreatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix |
| Retrospective Data Collection | – | –Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective data will be collected for up to 250 subjects across up to 7 academic medical centers that will receive Vivigen Cellular Bone Matrix for treatment of a fracture. Retrospective data will be collected for up to an additional 250 subjects that received a bone graft adjunct for treatment of a fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivigen Cellular Bone MatrixAllograft bone matrix | Other | Prospective Registry |
Primary outcome
Reintervention Rate
Time frame: 24 months
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
2 secondary outcomes
Fusion Rate
Time frame: 24 months
Patient Reported Outcome Measurement Information System (PROMIS) Scores
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Dorsch study director
LifeNet Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Nonunion of Fracture, run by LifeNet Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monique Alston-Epps (757-609-4378, monique_alstonepps@lifenethealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintervention Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.