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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNitin Agarwal

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patients < 18 years

Patients with a cervical spine pathology

Patients with spinal tumors

Patients with bone density (DEXA) scores < 2.0 will be excluded.

Trial design

Treatments tested in this trial

  • Use of Viper Prime/Expedium system with Fibergraft BG Putty

Treatment groups

No treatment groups listed

Sponsors and collaborators

Nitin Agarwal

Lead sponsor

University of Pittsburgh

Sponsor institution

DePuy Synthes

Collaborator