Actively Recruiting

Age: 18Years +
All Genders
ID06256458

Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBoneae Bone Graft Substitute in Acute Trauma Patients

Led by Artoss Inc. · Updated on 2025-02-12

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are documenting how orthopedic surgeons use NanoBoneae Bone Graft products in treating acute fractures caused by blunt or penetrating trauma, focusing on patient outcomes. This patient registry study tracks fracture healing through X-rays and assesses improvements in symptoms and function based on reports from both investigators and patients. The study also records any product-related adverse events to better understand the outcomes of using NanoBone in acute trauma cases. The study observes the use of NanoBoneae Bone Graft applied during surgery as either a stand-alone bone graft or combined with local bone, without other bone graft substitutes or biologic products. Surgeons independently decide the surgical technique and specific NanoBone product to use. This observational registry captures data at multiple time points including 2 weeks, 6 weeks, 3 months, and 6 months after treatment. Participants will undergo assessments including radiographic imaging to evaluate fracture healing and clinical evaluations of pain relief at scheduled intervals up to 6 months. Patient-reported outcome measures will also be collected to track symptom and function improvements. The study involves ongoing monitoring of treatment results and adherence to post-operative care plans to gather comprehensive data on the use and effectiveness of NanoBoneae Bone Graft in acute trauma patients.

CONDITIONS

Brief Title

Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects at least 18 years old at the time of injury
  • Acute fractures caused by blunt or penetrating trauma
  • Fractures located in the extremities or pelvis
  • Fractures requiring surgery
  • Surgery performed emergently, delayed, or staged up to 4 weeks from injury date
  • Bone grafting is clinically indicated for the fracture
Not Eligible

You will not qualify if you...

  • Fractures in certain locations: hand (metacarpals, phalanges), forefoot (metatarsals, phalanges), skull, spine
  • Fractures needing definitive stabilization beyond 4 weeks from injury date
  • Pathologic fractures due to cancer
  • Inability to follow post-operative care plan and complete follow-ups
  • Inability to complete patient-reported outcome measures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - Up to 4 weeks from injury date

Participants undergo surgery involving use of the NanoBone® Bone Graft device as determined by their surgeon, followed by immediate post-operative care.

Surgery performed emergently, delayed, or staged up to 4 weeks from injury

Post-operative Follow-up

Duration - 6 months

Participants are followed up to assess fracture healing, pain relief, and clinical outcomes through radiographic and patient-reported assessments.

Visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgery

Trial Site Locations

Total: 1 location

1

SSM Health St. Mary's Hospital

Madison, Wisconsin, United States, 53715

Actively Recruiting

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Research Team

J

James J Cassidy, Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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