Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NanoBone® Bone Graft.
- Who it may be relevant to
- Registry conditions: Fractures, Bone. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Radiographic evidence of fracture healing [Time frame: 2 weeks, 6 weeks, 3 months, 6 months]
Secondary outcome measures (1)
- Pain relief [Time frame: 2 weeks, 6 weeks, 3 months, 6 months]
Eligibility criteria
Inclusion criteria
- Subjects at least 18 years old at the time of injury
- 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
- Certain fracture locations (these apply to non-unions as well)
- Hand - metacarpals, phalanges
- Forefoot - metatarsals, phalanges
- Skull
- Spine
- Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
- Pathologic fractures secondary to malignancy
- Subjects unable to follow recommended post-operative plan and complete follow ups
- Subjects unable to complete patient reported outcome measures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- SSM Health St. Mary's Hospital — Madison
Identifiers
NCT: NCT06256458 · ART001