ACDF Using Structural Allograft vs. Tritanium C (NCT04388332) | Clinical Trial Compass
RecruitingNot Applicable
ACDF Using Structural Allograft vs. Tritanium C
United States60 participantsStarted 2020-08-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Time to the presence of fusion
Timeframe: 3 months post-operatively
2
Time to the presence of fusion
Timeframe: 6 months post-operatively
3
Time to the presence of fusion
Timeframe: 12 months post-operatively
Trial details
NCT IDNCT04388332
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
✕. 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