Clinical trial NCT06256458: Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fractures, Bone
Lead sponsor: Artoss Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already surgically treated for trauma but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon had determined that the use of a NanoBone product was clinically necessary for the patient. The choice of a NanoBone product was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic evidence of fracture healing
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
Secondary outcomes:
measure: Pain relief
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: SSM Health St. Mary's Hospital
state: Wisconsin
Study officials:
affiliation: SSM Health
name: Mitchell D Kuhl, DO
role: PRINCIPAL_INVESTIGATOR
References: