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Recruiting NCT06704919

Conduit Cages and Fibergraft BG Putty

— Observational Degenerative Disc Disease Herniated Disc

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of conduit cages and fibergraft BG Putty.
Who it may be relevant to
Registry conditions: Degenerative Disc Disease, Herniated Disc. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Use of conduit cages and fibergraft BG Putty
    Patients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.

Primary outcome measures

  • Fusion [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
Secondary outcome measures (4)
  • Visual Analog Scale (VAS) [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
  • Oswestry Disability Index [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
  • SF-12 [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
  • Neck Disability Index [Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]

Eligibility criteria

Inclusion criteria

  • 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.
  • Pathology to be between L2-S1 in the lumbar group.
  • Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
  • Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Exclusion criteria

  • 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
  • Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
  • Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Pittsburgh Medical Center — Pittsburgh

Identifiers

NCT: NCT06704919 · STUDY24040009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗