Conduit Cages and Fibergraft BG Putty

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

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Herniated Disc
• Intervention / Treatment: Device: Use of conduit cages and fibergraft BG Putty

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nitin Agarwal, MD; Phone Number: 9085311947; Email: nitin.agarwal@upmc.edu
• Study Contact Backup: Name: Rida Mitha, MD; Phone Number: 3147327092; Email: mithar@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Rida Mitha; Phone Number: 3147327092; Email: mithar@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with spinal conditions mentioned in inclusion/exclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
Oswestry Disability Index	We will have patients fill out validated tools for PROs to assess how the patient is doing	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
SF-12	We will have patients fill out validated tools for PROs to assess how the patient is doing	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
Neck Disability Index	We will have patients fill out validated tools for PROs to assess how the patient is doing	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Collaborators and Investigators

• Sponsor: Nitin Agarwal
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Nitin Agarwal, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: STUDY24040009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No