Adult Patient Outcomes After Spine Surgery with Fibergraft BG Putty/Viper Prime

Launched by NITIN AGARWAL · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the outcomes of spine surgery using a specific combination of implants, called the Viper Prime/Expedium spine systems, along with a special material known as Fibergraft Bioactive Glass. This combination is designed to help stabilize the spine and promote healing in patients who have conditions like degenerative disc disease, spondylolisthesis (a condition where a vertebra slips out of place), or spinal trauma. The trial aims to recruit adult patients who need spine surgery and will follow them for two years to see how well the surgery works, looking at factors like healing and any complications.

To be eligible for the trial, participants must be at least 18 years old and have a specific spinal condition that requires surgery to fuse 1 to 3 levels of the spine. However, those with certain conditions, such as cervical spine issues, severe osteoporosis, or a high body mass index (BMI), will not be included. Participants can expect to receive standard care during their surgery and will be monitored for two years after the procedure to track their recovery and any potential need for further surgery. This trial could provide valuable information about the effectiveness of these implants in helping patients recover from spine surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Have a radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, or pseudoarthrosis/failed fusion.
• • 3. Pathology of the thoracolumbar or sacral spine.
• • 4. Patients requiring fusion of 1-3 levels
• • 5. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.
• Exclusion Criteria:
• • 1. Patients \< 18 years
• • 2. Patients with a cervical spine pathology
• • 3. Patients with spinal tumors
• • 4. Patients with bone density (DEXA) scores \< 2.0 will be excluded.
• • 5. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.
• • 6. Patients with a BMI \> 40kg/m2
• • 7. Patients requiring fusion for more than 3 levels will be excluded