Recruiting

Fibergraft BG

Sponsor:

Nitin Agarwal

Code:

NCT06704906

Conditions

Spondylolisthesis, Lumbar Region

Spinal Trauma With Neurological Deficit

Degeneration of Lumbar Intervertebral Disc

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of Viper Prime/Expedium system with Fibergraft BG Putty

Study Details

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 ID

NCT06704906

Start date

Dec 20, 2024

Status verified date

Jan, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Fusion [ Time Frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months) ]

Central Contacts and Locations

Central contacts

Nitin Agarwal, MD

9085311947nitin.agarwal@upmc.edu

Rida Mitha, MD

3147327092mithar@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Rida Mitha

3147327092mithar@upmc.edu

More Information

Sponsor

Nitin Agarwal

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nitin Agarwal on 2026-01-22.