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โ† Trials
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Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime

Recruitingn/aAges 18 Years - anyAllNitin Agarwal
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In plain words

What the trial is, and whether it could suit you

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 re

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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
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What it tests

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

1 site
University of Pittsburgh Medical Center
Pittsburgh, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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