Conduit Cages and Fibergraft BG Putty

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNitin Agarwal

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Patients < 18 years

BMI > 40 kg/m2 to be excluded

Patients with a bone density (DEXA) score of <2.0 to be excluded

3 or more levels for ACDF or Lumbar interbody to be excluded

Trial design

Treatments tested in this trial

  • Use of conduit cages and fibergraft BG Putty

Treatment groups

No treatment groups listed

Sponsors and collaborators

Nitin Agarwal

Lead sponsor

University of Pittsburgh

Sponsor institution

DePuy Synthes

Collaborator