An observational study in Fractures, Bone, Nonunion of Fracture and Fractures, Open, sponsored by LifeNet Health. Recruiting at 4 sites in United States. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by LifeNet Health · Observational
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.
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 250 is above the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →LifeNet Health is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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:
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
Other: Vivigen Cellular Bone Matrix
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.
Allograft bone matrix
Reintervention Rate
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
Time frame: 24 months
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
Time frame: 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.
Time frame: 24 months
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for Jul 2028, 85 months after the start.
Of 86 observational studies under Fractures, Bone, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 124. This study's planned 85 months is above that.
How these figures are worked out, and which studies are left out of them.
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