Actively Recruiting

Age: 18Years +
All Genders
NCT06704919

Conduit Cages and Fibergraft BG Putty

Led by Nitin Agarwal · Updated on 2026-01-22

100

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

Sponsors

N

Nitin Agarwal

Lead Sponsor

D

DePuy Synthes

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Conduit Cages and Fibergraft BG Putty

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Radiograph-confirmed degenerative disc disease, ruptured or herniated discs
  • Pathology located in the cervical spine between C2 and T1
  • Pathology located in the lumbar spine between L2 and S1
  • Involvement of 1 to 2 contiguous spinal levels in both cervical and lumbar groups
  • Receiving surgery and devices as part of standard care prescribed by physician
Not Eligible

You will not qualify if you...

  • Age below 18 years
  • Body mass index (BMI) greater than 40 kg/m2
  • Bone density (DEXA) score less than 2.0
  • Involvement of 3 or more spinal levels for ACDF or lumbar interbody procedures
  • History of previous pseudoarthrosis or failed spondylodesis
  • Current smokers or those who quit smoking within 6 weeks before presentation

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

N

Nitin Agarwal, MD

CONTACT

R

Rida Mitha, MD

CONTACT

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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Conduit Cages and Fibergraft BG Putty | DecenTrialz