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

Nitin Agarwal100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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. 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

Outcomes

Primary Outcomes

Fusion

We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.

Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Secondary Outcomes

Visual Analog Scale (VAS)

We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Oswestry Disability Index (ODI)

We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Short form survey-12

We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Central Contacts

Nitin Agarwal, MD

CONTACT

9085311947 nitin.agarwal@upmc.edu

Rida Mitha, MD

CONTACT

3147327092 mithar@upmc.edu

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts