ACDF Using Structural Allograft vs. Tritanium C

Recruiting now · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID: NCT04388332
Run by: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
People needed: 60
Starts: 2020-08-20
Expected to finish: 2026-12-01
Last updated by the study team: 2025-11-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males or females ≥18 years of age, ≤ 80 years of age
Subject is skeletally mature
Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc
Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids
Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent (Prospective study)
Subjects that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study)
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)

You may not qualify if…

Patients may not be enrolled in the study if any of the following exclusion criteria are present:
Presence of an infection systemic or local
Presence of marked local inflammation
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
Use of bone growth stimulator
Subject has prior fusion at the levels to be treated
Subject has any neuromuscular deficit
Subject has any condition of senility, mental illness, or substance abuse
Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery in the judgement of the PI
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.
BMI≥40 kg/m2
Subject uses chronic corticosteroids
Subjects with current active psychiatric diagnosis or a personality disorder likely to interfere with the study
Subjects who smoke and do not plan to quit
Mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
Subject has any open wounds
Subject has inadequate tissue coverage over the operative site
Subject may be sensitive to titanium materials
Subject is missing 6 and/or 12 month clinical or radiographic follow-up (Retrospective study)

Where it is running

Allegheny Health Network — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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