NCT04388332 ACDF Using Structural Allograft vs. Tritanium C
| NCT ID | NCT04388332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
| Condition | Degenerative Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-08-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2020-08-20 with a primary completion date of 2026-12.
⚠ 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
This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.
Eligibility Criteria
Inclusion Criteria: 1. Males or females ≥18 years of age, ≤ 80 years of age 2. Subject is skeletally mature 3. Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc 4. Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids 5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent (Prospective study) 6. Subjects that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study) 7. Subjects that underwent one or two level anterior cervical discectomy and fusion with either standard of care structural allograft bone at any AHN facility from 01/01/2016 to 08/14/2023 (Retrospective study) • Note that these patients will be followed for a maximum of one year (up to 08/14/2024 for a patient enrolled at the end of this inclusion period) Exclusion Criteria: Patients may not be enrolled in the study if any of the following exclusion criteria are present: 1. Presence of an infection systemic or local 2. Presence of marked local inflammation 3. Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis 4. Use of bone growth stimulator 5. Subject has prior fusion at the levels to be treated 6. Subject has any neuromuscular deficit 7. Subject has any condition of senility, mental illness, or substance abuse 8. Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery in the judgement of the PI 9. Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Subject is pregnant or plans to become pregnant during the course of the study. 10. BMI≥40 kg/m2 11. Subject uses chronic corticosteroids 12. Subjects with current active psychiatric diagnosis or a personality disorder likely to interfere with the study 13. Subjects who smoke and do not plan to quit 14. Mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care 15. Subject has any open wounds 16. Subject has inadequate tissue coverage over the operative site 17. Subject may be sensitive to titanium materials 18. Subject is missing 6 and/or 12 month clinical or radiographic follow-up (Retrospective study)
Contact & Investigator
Nestor Tomycz, MD
PRINCIPAL INVESTIGATOR
Allegheny Health Network
Frequently Asked Questions
Who can join the NCT04388332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, 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 NCT04388332 currently recruiting?
Yes, NCT04388332 is actively recruiting participants. Contact the research team at nestor.tomycz@ahn.org for enrollment information.
Where is the NCT04388332 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04388332 clinical trial?
NCT04388332 is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The principal investigator is Nestor Tomycz, MD at Allegheny Health Network. The trial plans to enroll 60 participants.