RECRUITING

Conduit Cages and Fibergraft BG Putty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11
Study Completion:2029-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06704919

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,
  3. 3. Pathology of the cervical or lumbar spine.
  4. 4. Pathology to be between C2-T1 in the cervical group.
  5. 5. Pathology to be between L2-S1 in the lumbar group.
  6. 6. Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
  7. 7. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.
  1. 1. Patients \< 18 years
  2. 2. BMI \> 40 kg/m2 to be excluded
  3. 3. Patients with a bone density (DEXA) score of \<2.0 to be excluded
  4. 4. 3 or more levels for ACDF or Lumbar interbody to be excluded
  5. 5. Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
  6. 6. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

Contacts and Locations

Study Contact

Nitin Agarwal, MD
CONTACT
9085311947
nitin.agarwal@upmc.edu
Rida Mitha, MD
CONTACT
3147327092
mithar@upmc.edu

Principal Investigator

Nitin Agarwal, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Nitin Agarwal

  • Nitin Agarwal, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2029-03-30

Study Record Updates

Study Start Date2024-11
Study Completion Date2029-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Degenerative Disc Disease
  • Herniated Disc