Conduit Cages and Fibergraft BG Putty

NCT06704919 | Recruiting FDA Device

• 1 other identifier: STUDY24040009
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease; Herniated Disc

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analog Scale (VAS)

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

• Oswestry Disability Index

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

• SF-12

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

• Neck Disability Index

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

Interventions

Use of conduit cages and fibergraft BG Putty DEVICE

Patients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with spinal conditions mentioned in inclusion/exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• Patients \< 18 years
• BMI \> 40 kg/m2 to be excluded
• Patients with a bone density (DEXA) score of \<2.0 to be excluded
• or more levels for ACDF or Lumbar interbody to be excluded
• Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
• Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

Sponsors & Collaborators

• Nitin Agarwal: lead
• DePuy Synthes: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nitin Agarwal, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Agarwal, MD

CONTACT

9085311947; nitin.agarwal@upmc.edu

Rida Mitha, MD

CONTACT

3147327092; mithar@upmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 26, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)