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

Recruiting

• Conditions: Spondylolisthesis, Lumbar Region; Spinal Trauma with Neurological Deficit; Degeneration of Lumbar Intervertebral Disc

• Registration Number: NCT06704906
• Lead Sponsor: Nitin Agarwal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-26
• Study Start: 2024-12-20
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion	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 Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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
Oswestry Disability Index (ODI)	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
Short form survey-12	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

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States