RECRUITING

Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime

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 Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, 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, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. 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 VIPER PRIME/Expedium Spine System and Fibergraft BG Putty

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

NCT06704906

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, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, or pseudoarthrosis/failed fusion.
  3. 3. Pathology of the thoracolumbar or sacral spine.
  4. 4. Patients requiring fusion of 1-3 levels
  5. 5. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.
  1. 1. Patients \< 18 years
  2. 2. Patients with a cervical spine pathology
  3. 3. Patients with spinal tumors
  4. 4. Patients with bone density (DEXA) scores \< 2.0 will be excluded.
  5. 5. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.
  6. 6. Patients with a BMI \> 40kg/m2
  7. 7. Patients requiring fusion for more than 3 levels 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

  • Spondylolisthesis, Lumbar Region
  • Spinal Trauma With Neurological Deficit
  • Degeneration of Lumbar Intervertebral Disc