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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.

• The individual is 18 to 85 years of age.

• The individual is skeletally mature.

• 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.

• The individual is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Locations
United States
Massachusetts
UMass Memorial Health Care
Worcester
Time Frame
Start Date: 2021-07-19
Completion Date: 2025-04-30
Participants
Target number of participants: 40
Treatments
Other: Single arm subject is own control
Posterolateral fusion is bilateral, patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.
Sponsors
Leads: Artoss Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials