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

Description

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.

Conditions

Spondylolisthesis, Lumbar Region, Spinal Trauma With Neurological Deficit, Degeneration of Lumbar Intervertebral Disc

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spondylolisthesis, Lumbar Region
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nitin Agarwal,

Nitin Agarwal, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2029-03-30