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Recruiting NCT06704906

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of Viper Prime/Expedium system with Fibergraft BG Putty.
Who it may be relevant to
Registry conditions: Spondylolisthesis, Lumbar Region, Spinal Trauma With Neurological Deficit, Degeneration of Lumbar Intervertebral Disc. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Use of Viper Prime/Expedium system with Fibergraft BG Putty
    Patients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.

Primary outcome measures

  • Fusion [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
Secondary outcome measures (3)
  • Visual Analog Scale (VAS) [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
  • Oswestry Disability Index (ODI) [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
  • Short form survey-12 [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients < 18 years
  • Patients with a cervical spine pathology
  • Patients with spinal tumors
  • Patients with bone density (DEXA) scores < 2.0 will be excluded.
  • Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.
  • Patients with a BMI > 40kg/m2
  • Patients requiring fusion for more than 3 levels will be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Pittsburgh Medical Center — Pittsburgh

Identifiers

NCT: NCT06704906 · STUDY24040006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗