Conduit Cages and Fibergraft BG Putty

Last updated: December 23, 2024
Sponsor: Nitin Agarwal
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Treatment

Use of conduit cages and fibergraft BG Putty

Clinical Study ID

NCT06704919
STUDY24040009
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured orherniated 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 thetreating physician.

Exclusion

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 presentationwill be excluded

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Use of conduit cages and fibergraft BG Putty
Phase:
Study Start date:
November 04, 2024
Estimated Completion Date:
March 30, 2029

Connect with a study center

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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