Using conduit cages and Fibergraft BG Putty for spine surgery

Assess Clinical and Radiographic Outcomes of Conduit Cages and Fibergraft in Cervical and Lumbar Procedures

This study is testing if using special cages and a new type of putty during spine surgery can help people with disc problems and spine instability recover better over two years.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06704919 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the clinical and radiographic outcomes of patients with degenerative disc disease and instabilities in the cervical and lumbar spine who receive conduit cages and Fibergraft Bioactive Glass (BG) Putty. The study will recruit skeletally mature patients with specific spinal pathologies and follow them for two years to assess the effectiveness of these implants in restoring intervertebral height and facilitating fusion. The research focuses on patients with conditions such as herniated discs and pseudarthrosis, providing a comprehensive analysis of their recovery and outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed degenerative disc disease or herniated discs affecting specific levels of the cervical or lumbar spine.

Not a fit: Patients under 18, those with a high BMI, or individuals with previous failed spinal surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance spinal fusion outcomes and improve recovery for patients with degenerative disc disease.

How similar studies have performed: Previous studies have explored the use of conduit cages in spinal procedures, but this specific combination with Fibergraft has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,
3. Pathology of the cervical or lumbar spine.
4. Pathology to be between C2-T1 in the cervical group.
5. Pathology to be between L2-S1 in the lumbar group.
6. Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
7. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Exclusion Criteria:

1. Patients \< 18 years
2. BMI \> 40 kg/m2 to be excluded
3. Patients with a bone density (DEXA) score of \<2.0 to be excluded
4. 3 or more levels for ACDF or Lumbar interbody to be excluded
5. Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
6. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Nitin Agarwal, MD — University of Pittsburgh
• Study coordinator: Nitin Agarwal, MD

Conditions Degenerative Disc Disease; Herniated Disc