NanoBone® 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Radiographic evidence of fracture healing — 2 weeks, 6 weeks, 3 months, 6 months AP and lateral x-rays
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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