Clinical trial NCT06704906: Adult Patient Outcomes After Spine Surgery with Fibergraft BG Putty/Viper Prime
Official title: Assess Clinical and Radiographic Outcomes of VIPER PRIME/Expedium Spine System and Fibergraft BG Putty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spondylolisthesis, Lumbar Region
Spinal Trauma with Neurological Deficit
Degeneration of Lumbar Intervertebral Disc
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2024-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with spinal conditions mentioned in inclusion/exclusion criteria

Brief summary: 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: 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

Primary outcomes:
measure: Fusion
timeFrame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
measure: Oswestry Disability Index (ODI)
timeFrame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
measure: Short form survey-12
timeFrame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Nitin Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: