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

NCT ID: NCT06704906

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2029-03-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

Nitin Agarwal

OTHER

Sponsor Role: lead

Responsible Party

Nitin Agarwal

Associate Professor, Neurosurgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nitin Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nitin Agarwal, MD

Role: CONTACT

nitin.agarwal@upmc.edu

9085311947

Rida Mitha, MD

Role: CONTACT

mithar@upmc.edu

3147327092

Facility Contacts

Rida Mitha

Role: primary

mithar@upmc.edu

3147327092

Other Identifiers

STUDY24040006

Identifier Type: -

Identifier Source: org_study_id