Actively Recruiting
Comparison of Clinical Outcomes Following ACDF With Instrumentation 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
N/A
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 research aims to observe and compare the outcomes of patients undergoing anterior cervical discectomy and fusion (ACDF) for degenerative disc disease. The study looks at two types of procedures: one using a device called Tritanium C and the other using structural allograft bone with plates. It is a combined observational study including both retrospective and prospective data collection to evaluate fusion success and adverse events. The study involves two groups: a retrospective cohort of up to 40 patients who previously received ACDF with structural allograft bone and plates, and a prospective group of 20 patients receiving Tritanium C as part of their standard care. Data includes patients treated at one or two contiguous cervical spine levels. The retrospective group will be matched to the prospective patients in a 2:1 ratio. Both cohorts have follow-up visits and imaging at baseline, 6 months, and 12 months post-operation to assess fusion and other outcomes. Participants will have clinical assessments including neck disability, neck and arm pain, and neurological status at baseline and during follow-up visits at 3, 6, and 12 months post-operation. Researchers will collect imaging and questionnaire data to measure fusion success and adverse events over time. The total participation period for retrospective patients includes up to one year of follow-up, while prospective patients are monitored through their standard care schedule. The study is conducted without blinding or randomization.
CONDITIONS
Brief 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 cervical spine levels from C2 to T1
- Received six weeks of non-operative therapy such as injections, physical therapy, or oral steroids
- Willing to sign informed consent (prospective study)
- Undergoing one or two level anterior cervical discectomy and fusion with Tritanium C (prospective study)
- Underwent one or two level ACDF with structural allograft bone at AHN between 01/01/2016 and 08/14/2023 (retrospective study)
You will not qualify if you...
- Presence of systemic or local infection
- Marked local inflammation
- Abnormalities affecting bone remodeling such as severe osteoporosis, bone absorption, osteopenia, tumors, active infection at site, or metabolic disorders affecting bone formation
- Use of bone growth stimulator
- Prior fusion at the treated levels
- Any neuromuscular deficit
- Conditions like senility, mental illness, or substance abuse
- Other medical or surgical conditions precluding spinal implant surgery benefit
- Rapid joint disease, bone absorption, osteopenia, osteomalacia, or osteoporosis
- Pregnancy or plans to become pregnant during the study
- BMI 40 kg/m2 or higher
- Chronic corticosteroid use
- Current active psychiatric diagnosis or personality disorder interfering with study
- Smoking without plan to quit
- Mental or neuromuscular disorders risking fixation failure or complications
- Open wounds
- Inadequate tissue coverage over operative site
- Sensitivity to titanium materials
- Missing 6 or 12 month clinical or radiographic follow-up (retrospective study)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day of surgery
Participants undergo one or two level anterior cervical discectomy and fusion surgery with either structural allograft or the Tritanium C device.
1 surgery visit (in-person)
Duration - Up to 12 months post-operatively
Participants have follow-up visits to monitor fusion progress, neck disability, pain, sensory and motor function, and adverse events.
Follow-up visits at 3, 6, and 12 months post-operatively
Trial Site Locations
Total: 1 location
1
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
Research Team
N
Nestor Tomycz, MD
A
Alexander Yu, MD
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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