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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Nitin Agarwal, MD
nitin.agarwal@upmc.edu
9085311947
Backup
Rida Mitha, MD
mithar@upmc.edu
3147327092
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 100
Sponsors
Collaborators: DePuy Synthes
Leads: Nitin Agarwal

This content was sourced from clinicaltrials.gov