| NCT ID | NCT06704919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nitin Agarwal |
| Condition | Degenerative Disc Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-11-04 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion 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. Exclusion Criteria: 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
Contact & Investigator
Nitin Agarwal, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06704919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06704919 currently recruiting?
Yes, NCT06704919 is actively recruiting participants. Contact the research team at nitin.agarwal@upmc.edu for enrollment information.
Where is the NCT06704919 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06704919 clinical trial?
NCT06704919 is sponsored by Nitin Agarwal. The principal investigator is Nitin Agarwal, MD at University of Pittsburgh. The trial plans to enroll 100 participants.