RecruitingNot Applicable

Conduit Cages and Fibergraft BG Putty

United States100 participantsStarted 2024-11-04

Plain-language summary

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. 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.

Who can participate

Age range

18 Years

Sex

ALL

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Inclusion criteria

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fusion

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

Trial details

NCT IDNCT06704919

SponsorNitin Agarwal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

Nitin Agarwal, MD

9085311947 nitin.agarwal@upmc.edu

View on ClinicalTrials.gov More Degenerative Disc Disease trials