Fractures, Bone
Conditions
Brief summary
This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.
Detailed description
This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments. The primary objective of this study is to document and analyze the use of NanoBone products in acute trauma cases (as a stand-alone bone graft, or in combination with local bone only, no other bone graft substitute or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.
Interventions
DEVICENanoBone® Bone Graft
The surgical technique used by the surgeon and the choice of the specific NanoBone product is or was determined solely by the surgeon and is independent of this observational study.
Sponsors
Artoss Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects at least 18 years old at the time of injury 2. Acute fractures, resulting from blunt or penetrating trauma * In the extremities or pelvis * Requiring surgery * Treated emergently, delayed or staged up to 4 weeks from the date of injury * Where bone grafting is clinically indicated
Exclusion criteria
1. Certain fracture locations (these apply to non-unions as well) * Hand - metacarpals, phalanges * Forefoot - metatarsals, phalanges * Skull * Spine 2. Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury 3. Pathologic fractures secondary to malignancy 4. Subjects unable to follow recommended post-operative plan and complete follow ups 5. Subjects unable to complete patient reported outcome measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evidence of fracture healing | 2 weeks, 6 weeks, 3 months, 6 months | AP and lateral x-rays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | 2 weeks, 6 weeks, 3 months, 6 months | Visual Analog Scale (VAS) pain score at fracture site. 0-10 scale, lower score means less pain. |
Countries
United States
Contacts
Primary ContactJames J Cassidy, Ph.D.
Outcome results
None listed