RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-01
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06256458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects at least 18 years old at the time of injury
  2. 2. Acute fractures, resulting from blunt or penetrating trauma
  3. * In the extremities or pelvis
  4. * Requiring surgery
  5. * Treated emergently, delayed or staged up to 4 weeks from the date of injury
  6. * Where bone grafting is clinically indicated
  1. 1. Certain fracture locations (these apply to non-unions as well)
  2. * Hand - metacarpals, phalanges
  3. * Forefoot - metatarsals, phalanges
  4. * Skull
  5. * Spine
  6. 2. Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
  7. 3. Pathologic fractures secondary to malignancy
  8. 4. Subjects unable to follow recommended post-operative plan and complete follow ups
  9. 5. Subjects unable to complete patient reported outcome measures

Contacts and Locations

Study Contact

James J Cassidy, Ph.D.
CONTACT
320-259-4321
jcassidy@artossinc.com

Principal Investigator

Mitchell D Kuhl, DO
PRINCIPAL_INVESTIGATOR
SSM Health

Study Locations (Sites)

SSM Health St. Mary's Hospital
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: Artoss Inc.

  • Mitchell D Kuhl, DO, PRINCIPAL_INVESTIGATOR, SSM Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Fractures, Bone