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Can a donated bone matrix help broken bones heal?

NCT ID NCT04299022

Disease control Sponsor: LifeNet Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are collecting data on ViviGen, a donated cellular bone matrix used as a graft during orthopaedic surgery. The study follows patients with acute fractures, delayed healing, non-union fractures, or spinal fusion to see how often they need a second operation within a year and how well their bones fuse. It combines possible future patients with a review of past medical records, aiming to understand the safety and effectiveness of this graft material in real-world care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ViviGen cellular bone matrix, a donated bone graft material
What this could lead to
If ViviGen helps fractures heal reliably, it could give surgeons a dependable option for broken bones that are slow to mend or fail to join.
What could go wrong
This is an observational registry, not a randomized trial, so it cannot prove ViviGen causes better healing. Results may reflect surgeon selection or patient factors rather than the graft itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Patients unable to understand either an English or Spanish consent will be excluded. 2. Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.

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Conditions

The condition(s) this trial relates to.

bone fracture Femoral Fractures Fractures, Open Fractures, Ununited tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture arm Fracture of femur Fracture, tibial Fractures, bone Fractures, open Fractures, ununited Nonunion of fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Medical Center

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • OrlandoHealth

    RECRUITING

    Orlando, Florida, 32806, United States

  • RWJBarnabas Health

    RECRUITING

    Jersey City, New Jersey, 07302, United States

  • Sentara Hospitals

    COMPLETED

    Norfolk, Virginia, 23507, United States

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