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ACTIVE NOT RECRUITING

NCT04615260

Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.

Sponsor: Artoss Inc.

View on ClinicalTrials.gov

Summary

The objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral fusion procedures with or without commercially available rigid spinal instrumentation. Our hypothesis is that the Nanobone synthetic bone graft will be as effective at creating a fusion in the lumbar spine as compared with a local bone graft. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.

Official title: Comparison of Fusion Success Between NanoBone Synthetic Bone Graft and Local Autogenous Bone Graft in Posterolateral Spinal Fusion

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-07-19

Completion Date

2025-04-30

Last Updated

2025-02-12

Healthy Volunteers

Conditions

Degenerative Disc Disease Spondylolisthesis

Interventions

DEVICE

NanoBone

Nanobone® Synthetic Bone Graft is a nanocrystalline hydroxyapatite imbedded in a silica gel matrix. The nanocrystalline structure accurately replicates autologous hydroxyapatite and the silica gel matrix that rapidly transforms into an osteogenic matrix post-implantation. NanoBone promotes remodeling by acting as a strong osteoinductive material. NanoBone® is available as a putty.

Inclusion Criteria: 1. The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC. 2. The individual is 18 to 85 years of age. 3. The individual is skeletally mature. 4. The individual has been diagnosed with 1 or 2 level degenerative disc disease or spondylolisthesis grade 1-3 with or without spinal stenosis, requiring posterolateral spinal fusion surgery with bone grafting. 5. The individual is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: 1. The individual has had any previous attempts at fusion, at any lumbar levels. 2. The individual is morbidly obese (defined as 100 lbs over the recommended ideal weight as described in the Metropolitan Life Height and Weight Tables for Men and Women and or having a BMI \>39). 3. Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated. 4. Patients with systemic collagen, bone or mineralization dysfunction (such as Paget's disease, osteogenesis imperfecta, Ehlers-Danlos Syndrome). 5. Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependent diabetes mellitus type II. (definition based on the glycosylated Haemoglobin level) 6. Patients who are suffering from autoimmune disease. 7. Patients who previously underwent chemotherapy, immunosuppressive disease or radiation to the local area. 8. Patients who received or are currently receiving corticosteroids (\> 2 years \> 5 mg prednisolone equivalent/d). 9. Patients with active local or systemic infection. 10. Patients with any known active malignancy. 11. Patients with other concurrent physical or mental conditions which are likely to affect their outcome. 12. Patient unable to consent for themselves 13. Pregnant women 14. Non-English speaking subjects. These subjects are excluded because they would not be able to complete the English-language surveys required during this study. Only English language versions of these surveys have been validated. 15. Prisoners 16. Patients less than 18 years old

Locations (1)

UMass Memorial Health Care

Worcester, Massachusetts, United States