ACDF Using Structural Allograft vs. Tritanium C
Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
60 participants
Aug 20, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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)
Exclusion Criteria18
- 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)
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Interventions
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
Subjects will receive the Tritanium C anterior cervical cage which is intended to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04388332