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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Dec 20, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2028

Completion

Mar 30, 2029

Study Design

Enrollment

100 participants (estimated)

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

• Nitin Agarwal, MD
  9085311947
  [email protected]
• Rida Mitha, MD
  3147327092
  [email protected]

Locations (1)

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