Comparing two methods for cervical spine surgery

Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C

This study is testing whether using Tritanium C or structural allograft bone during cervical spine surgery leads to better healing and fewer problems for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT04388332 on ClinicalTrials.gov

What this trial studies

This study observes the outcomes of patients undergoing anterior cervical discectomy and fusion (ACDF) using either Tritanium C or structural allograft bone. It includes a retrospective cohort of patients treated with structural allograft and a prospective cohort of patients receiving Tritanium C. The study aims to compare the rate of fusion success and adverse events between these two groups. Data will be collected from medical records and follow-up visits to assess radiographic outcomes and patient-reported outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with degenerative disc disease who have not responded to non-operative therapy.

Not a fit: Patients who have not undergone prior non-operative therapy or those with contraindications for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the more effective surgical method for treating degenerative disc disease, leading to better patient outcomes.

How similar studies have performed: Other studies have shown success with similar surgical approaches, but this specific comparison is novel.

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)

Where this trial is running

Pittsburgh, Pennsylvania

• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Nestor Tomycz, MD — Allegheny Health Network
• Study coordinator: Nestor Tomycz, MD

Conditions: Degenerative Disc Disease, Tritanium C, Structural Bone Graft, Anterior Cervical Discectomy and Fusion