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NCT04299022 · ClinicalTrials.gov registry record
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
A clinical trial of Fractures, Bone and Fractures, Open, sponsored by LifeNet Health.
- Recruiting
- Registry status
- 250
- Enrollment target
- 4
- Study locations
NCT04299022: Recruiting study of Fractures, Bone and Fractures, Open, sponsored by LifeNet Health.
NCT04299022 is a study of Fractures, Bone and Fractures, Open that is actively recruiting participants, run by LifeNet Health. The registered enrollment target is 250 participants, below the 1,925-participant average among 12 other Fractures, Bone trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04299022, a study of Fractures, Bone and Fractures, Open, is actively recruiting participants, sponsored by LifeNet Health.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
Conditions Studied
Interventions
- OTHER Vivigen Cellular Bone Matrix
Study Locations (4)
Florida
- OrlandoHealth - Orlando
New Jersey
- RWJBarnabas Health - Jersey City
North Carolina
- Duke University Medical Center - Durham
Virginia
- Sentara Hospitals - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2026-07-31 |
What NCT04299022 shows while recruiting
NCT04299022 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,925-participant average among 12 other Fractures, Bone trials with a reported enrollment target (87% lower).
The record links to 7 conditions, with Fractures, Bone appearing as the primary indexed condition, and to 1 intervention - of which Vivigen Cellular Bone Matrix is the first listed.
NCT04299022 reports a single indexed study location in Florida, New Jersey, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04299022 about?
NCT04299022 is a clinical study titled "Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care". 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.
What is the current status of trial NCT04299022?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2021-06-01. Estimated completion is 2026-07-31.
What conditions does trial NCT04299022 study?
This clinical trial studies the following conditions: Fractures, Bone, Fractures, Open, Nonunion of Fracture, Fracture of Femur, Fractures, Ununited.
What interventions are being tested in trial NCT04299022?
The interventions under investigation include: Vivigen Cellular Bone Matrix (OTHER).
Who is sponsoring clinical trial NCT04299022?
This trial is sponsored by LifeNet Health, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04299022 being conducted?
This trial has 4 study locations across Florida, New Jersey, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fractures, Bone
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04299022's enrollment target sits among peer trials
250 2nd of 12 the highest of 12 other Fractures, Bone trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fractures, Bone trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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