Actively Recruiting
Assess Clinical and Radiographic Outcomes of Conduit Cages and Fibergraft in Cervical and Lumbar Spine Procedures
Led by Nitin Agarwal · Updated on 2026-01-22
100
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
N
Nitin Agarwal
Lead Sponsor
D
DePuy Synthes
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with degenerative disc disease and instabilities in the cervical and lumbar spine who experience radicular symptoms, herniated or ruptured discs, pseudarthrosis, and spondylodesis. The study aims to evaluate the clinical and radiographic outcomes of using Conduit cages combined with Fibergraft Bioactive Glass (BG) Putty, which is designed to mimic natural bone healing. Patients will be followed for two years to assess fusion, complication rates, and any revision surgeries. The study involves patients who require spine surgery as part of their standard care and who receive the Conduit cages and Fibergraft BG Putty implants. These devices are used to restore intervertebral height and facilitate fusion at one or more spine levels, specifically between C2-T1 in the cervical spine and L2-S1 in the lumbar spine. Data will be collected through routine scans and patient-reported outcome measures (PROMs) at baseline and multiple postoperative timepoints over two years. Participants will undergo evaluations including radiographs and questionnaires such as the Visual Analog Scale (VAS), Oswestry Disability Index, SF-12, and Neck Disability Index at baseline and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. Researchers will monitor fusion status, clinical outcomes, and any complications or revision surgeries during the two-year follow-up. All assessments will be part of standard care, and data will be gathered through chart reviews.
CONDITIONS
Brief Title
Conduit Cages and Fibergraft BG Putty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Radiographic diagnosis of degenerative disc disease, ruptured or herniated discs
- Pathology located in cervical spine between C2 and T1 or lumbar spine between L2 and S1
- Patients with 1-2 contiguous spine levels affected in cervical or lumbar groups
- Patients receiving spine surgery and implant devices as standard care prescribed by their physician
You will not qualify if you...
- Age under 18 years
- Body mass index (BMI) over 40 kg/m2
- Bone density (DEXA) score less than 2.0
- Three or more spine levels affected requiring surgery
- Previous pseudoarthrosis or failed spine fusion surgery
- Current smokers or those who quit smoking within 6 weeks prior to presentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Consent for participation is signed at the same time as consent for surgery.
Duration - Up to 1 day for surgery and immediate care
Participants undergo spine surgery using conduit cages and Fibergraft BG Putty as standard care.
Surgery occurs as part of routine healthcare.
Duration - 24 months
Participants have follow-up visits for clinical and radiographic assessment of fusion and patient-reported outcomes.
Visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
N
Nitin Agarwal, MD
R
Rida Mitha, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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