Prospective Registry to Evaluate Outcomes of NanoBone® Bo... | NCT06256458

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

NCT06256458

Sponsor

Artoss Inc.

Status

Recruiting

Last Update Posted

Feb 12, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Fractures, Bone

Interventions

NanoBone® Bone Graft

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Feb 5, 2024

First Submission Date that Met QC Criteria

Feb 5, 2024

First Posted Date

Feb 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2025

Last Update Posted Date

Feb 12, 2025Actual

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
NanoBone® Bone Graft	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic evidence of fracture healing	AP and lateral x-rays	2 weeks, 6 weeks, 3 months, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Pain relief	Visual Analog Scale (VAS) pain score at fracture site. 0-10 scale, lower score means less pain.	2 weeks, 6 weeks, 3 months, 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample