Conduit Cages and Fibergraft BG Putty

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Conduit Cages and Fibergraft BG Putty

Condition
Degenerative Disc Disease
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nitin Agarwal,

Nitin Agarwal, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2029-03-30