NCT06256458 · Artoss Inc.
Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma
(ARTIST)
What this study is about
This conducted at multiple hospitals forward-looking 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Treated emergently, delayed or staged up to 4 weeks from the date of injury
- Where bone grafting is clinically indicated
Exclusion criteria
- Certain fracture locations (these apply to non-unions as well)
- Hand - metacarpals, phalanges
- Forefoot - metatarsals, phalanges
- Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
- Pathologic fractures secondary to malignancy
- Subjects unable to follow recommended post-operative plan and complete follow ups
- Subjects unable to complete patient reported outcome measures
Where
- Madison, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2025 · Source of record for eligibility and locations