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Conduit Cages and Fibergraft BG Putty

Recruitingn/aAges 18 Years - anyAllNitin Agarwal
NCT06704919 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, 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, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis

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📋 Eligibility rules (as published)
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
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What it tests

  • Use of conduit cages and fibergraft BG Putty
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Where

1 site
University of Pittsburgh Medical Center
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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