Status:
ACTIVE_NOT_RECRUITING
Artoss Prospective Spine Registry Outcomes
Lead Sponsor:
Artoss Inc.
Conditions:
Spinal Fusion
Eligibility:
All Genders
18+ years
Brief Summary
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining r...
Detailed Description
This multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the NanoBone products along with relevant patient outcomes. These outc...
Eligibility Criteria
Inclusion
- Patient aged 18 years or older
- Patient is diagnosed with a degenerative spine disorder requiring spinal fusion, has failed conservative treatment, and has decided to undergo surgery.
- The surgeon has determined that a NanoBone product is or was clinically indicated, and will use or have used the product as a stand-alone bone graft substitute or in combination with local autograft only (no iliac crest harvesting, other BGS, or biologic {defined as containing growth factors, cytokines, proteins, or cells} used).
- Patient capable of understanding the content of the Informed Consent Form
- Patient willing and able to participate in the registry protocol including SOC follow-up visits and clinical evaluations.
- Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the Declaration of Helsinki.
Exclusion
- • Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative disease (other than degenerative disc disease)
- Severely impaired renal function
- Hypercalcemia, abnormal calcium metabolism
- Existing acute or chronic infections, especially at the site of the operation
- Inflammatory bone disease such as osteomyelitis
- Malignant tumors
- Patients who are or plan to become pregnant.
- Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04439032
Start Date
August 3 2020
End Date
June 30 2025
Last Update
February 12 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
OrthoArizona
Chandler, Arizona, United States, 85226
2
Sonoran Spine
Tempe, Arizona, United States, 85281
3
SENTA Clinic
San Diego, California, United States, 92108
4
Hartford Health Care
Hartford, Connecticut, United States, 06102