Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma
ConditionFractures, Bone
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorArtoss Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subjects at least 18 years old at the time of injury
Acute fractures, resulting from blunt or penetrating trauma
In the extremities or pelvis
Requiring surgery
Disqualifiers
Certain fracture locations (these apply to non-unions as well)
Hand - metacarpals, phalanges
Forefoot - metatarsals, phalanges
Skull
Trial population
All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already surgically treated for trauma but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon had determined that the use of a NanoBone product was clinically necessary for the patient. The choice of a NanoBone product was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
NanoBone® Bone Graft
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Radiographic evidence of fracture healing
AP and lateral x-rays
Time frame
2 weeks, 6 weeks, 3 months, 6 monthsSecondary outcomes
1
Pain relief
Visual Analog Scale (VAS) pain score at fracture site. 0-10 scale, lower score means less pain.
Time frame
2 weeks, 6 weeks, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov