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

Fractures, Bone Clinical Trial

— ARTIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256458
• Other study ID #: ART001
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• Source: Artoss Inc.
• Contact: James J Cassidy, Ph.D.
• Phone: 320-259-4321
• Email: jcassidy[@]artossinc.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	SSM Health St. Mary's Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Artoss Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic evidence of fracture healing	AP and lateral x-rays	2 weeks, 6 weeks, 3 months, 6 months
Secondary	Pain relief	VAS pain score at fracture site	2 weeks, 6 weeks, 3 months, 6 months
Secondary	Health status	EuroQol-5D	2 weeks, 6 weeks, 3 months, 6 months