Conduit Cages and Fibergraft BG Putty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNitin Agarwal
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Adult patients with spinal conditions mentioned in inclusion/exclusion criteria
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Use of conduit cages and fibergraft BG Putty
DevicePatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Fusion
We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.
Time frame
2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)Secondary outcomes
1
Visual Analog Scale (VAS)
We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively
Time frame
2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)2
Oswestry Disability Index
We will have patients fill out validated tools for PROs to assess how the patient is doing
Time frame
2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)3
SF-12
We will have patients fill out validated tools for PROs to assess how the patient is doing
Time frame
2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)4
Neck Disability Index
We will have patients fill out validated tools for PROs to assess how the patient is doing
Time frame
2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov