Assess Clinical and Radiographic Outcomes of VIPER PRIME/Expedium Spine System and Fibergraft BG Putty

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.

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

• Age ≥ 18 years

• 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.

• Pathology of the thoracolumbar or sacral spine.

• Patients requiring fusion of 1-3 levels

• Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Nitin Agarwal, MD
nitin.agarwal@upmc.edu
9085311947
Backup
Rida Mitha, MD
mithar@upmc.edu
3147327092
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 100
Sponsors
Collaborators: DePuy Synthes
Leads: Nitin Agarwal

This content was sourced from clinicaltrials.gov