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Recruiting

NCT Number: NCT06704906

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

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.

Recruiting

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Key information

Conditions

Spondylolisthesis, Lumbar Region Bone Diseases Degeneration of Lumbar Intervertebral Disc Musculoskeletal Diseases Spinal Diseases Spinal Trauma With Neurological Deficit Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Rida Mitha

CONTACT

[email protected]

3147327092

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Fusion

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

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

Secondary outcomes

  1. Visual Analog Scale (VAS)

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

    We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

  2. Oswestry Disability Index (ODI)

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

    We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

  3. Short form survey-12

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

    We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Nitin Agarwal, MD

CONTACT

[email protected]

9085311947

Rida Mitha, MD

CONTACT

[email protected]

3147327092

Sponsors and collaborators

Lead sponsor

Nitin Agarwal

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

Assess Clinical and Radiographic Outcomes of VIPER PRIME/Expedium Spine System and Fibergraft BG Putty

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Nov 26, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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