Actively Recruiting
ACDF Using Structural Allograft vs. Tritanium C
Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2025-11-14
60
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
Sponsors
A
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Lead Sponsor
S
Stryker Spine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ACDF Using Structural Allograft vs. Tritanium C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years
- Skeletally mature
- Diagnosed with degenerative disc disease at one or two contiguous levels from C2 to T1
- Completed six weeks of non-operative therapy such as injections, physical therapy, or oral steroids
- Understands and agrees to sign informed consent (for prospective participants)
- Will undergo one or two level anterior cervical discectomy and fusion with Tritanium C (prospective study)
- Underwent one or two level anterior cervical discectomy and fusion with structural allograft bone from 01/01/2016 to 08/14/2023 at the study site (retrospective study)
- Have standard clinic follow-up visits at 6 and 12 months with imaging available for assessment
You will not qualify if you...
- Presence of systemic or local infection
- Marked local inflammation
- Any abnormality affecting bone remodeling such as severe osteoporosis, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or metabolic disorders affecting bone formation
- Use of bone growth stimulators
- Prior fusion at the levels to be treated
- Neuromuscular deficits
- Conditions such as senility, mental illness, or substance abuse
- Other medical or surgical conditions that would prevent benefit from spinal implant surgery as judged by the investigator
- Rapid joint disease, osteomalacia, osteoporosis
- Pregnancy or plans to become pregnant during the study
- Body mass index of 40 kg/m2 or higher
- Chronic corticosteroid use
- Current active psychiatric diagnosis or personality disorder likely to interfere with the study
- Smoking without plans to quit
- Mental or neuromuscular disorders increasing risk of fixation failure or postoperative complications
- Open wounds or inadequate tissue coverage over the surgical site
- Sensitivity to titanium materials
- Missing 6 and/or 12 month clinical or imaging follow-up (retrospective study)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
Research Team
N
Nestor Tomycz, MD
CONTACT
A
Alexander Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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