Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma
NCT ID: NCT06256458
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-12-01
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Artoss Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mitchell D Kuhl, DO
Role: PRINCIPAL_INVESTIGATOR
SSM Health
Locations
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SSM Health St. Mary's Hospital
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ART001
Identifier Type: -
Identifier Source: org_study_id
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