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

NCT06704906 | Recruiting FDA Device

• 1 other identifier: STUDY24040006
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fusion

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

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

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

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

• Oswestry Disability Index (ODI)

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

• Short form survey-12

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

Interventions

Use of Viper Prime/Expedium system with Fibergraft BG Putty DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with spinal conditions mentioned in inclusion/exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitin Agarwal: lead
• DePuy Synthes: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Nitin Agarwal, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Agarwal, MD

CONTACT

9085311947; nitin.agarwal@upmc.edu

Rida Mitha, MD

CONTACT

3147327092; mithar@upmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 26, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)