Recruiting

NanoBone®

Sponsor:

Artoss Inc.

Code:

NCT06256458

Conditions

Fractures, Bone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NanoBone® Bone Graft

Study Details

Brief 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.

Conditions

Fractures, Bone

Study ID

NCT06256458

Start date

Dec 1, 2023

Status verified date

Feb, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Radiographic evidence of fracture healing [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

James J Cassidy, Ph.D.

320-259-4321jcassidy@artossinc.com

Locations

SSM Health St. Mary's Hospital

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Mitchell D Kuhl, DO

608-294-6464mitch.kuhl@ssmhealth.com

More Information

Sponsor

Artoss Inc.

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Artoss Inc. on 2025-02-12.