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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivigen Cellular Bone Matrix | Other | Allograft bone matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reintervention Rate | the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Patient Reported Outcome Measurement Information System (PROMIS) Scores |
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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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barry Saxton, P.A.-C. | Contact | 404 314 4903 | barry_saxton@lifenethealth.org | |
| Alyce Jones, Ph.D. | Contact | alyce_jones@lifenethealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Alyce Jones, Ph.D | LifeNet Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrlandoHealth | Recruiting | Orlando | Florida | 32806 | United States |
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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.
| 24 months |
| RWJBarnabas Health | Not yet recruiting | Jersey City | New Jersey | 07302 | United States |
|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Sentara Hospitals | Recruiting | Norfolk | Virginia | 23507 | United States |
|
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D005599 | Fractures, Ununited |
| D005597 | Fractures, Open |
| D013978 | Tibial Fractures |
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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