What is this study trying to find out about degenerative disc disease?

This study observes outcomes of patients undergoing anterior cervical discectomy and fusion using either Tritanium C or structural allograft bone with plates. Researchers are comparing fusion success and adverse events to better understand these treatment options. The study is sponsored by Allegheny Singer Research Institute.

Who may be eligible for this degenerative disc disease clinical trial?

Adults aged 18 to 80 years diagnosed with degenerative disc disease at one or two cervical spine levels may be eligible. Participants should have tried six weeks of non-surgical treatments and be able to undergo surgery. Both males and females can join. Please review eligibility criteria for more details.

Is there any cost to participate in this degenerative disc disease clinical trial?

Study-related care, including the surgical procedure and all trial visits, is provided at no cost. However, any personal travel expenses are not guaranteed to be covered and may vary. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID04388332

Comparing Outcomes of Anterior Cervical Discectomy and Fusion Using Structural Allograft or Tritanium C Device in Adults with Degenerative Disc Disease

Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2025-11-14

Participants Needed

Research Sites

N/A

Total Duration

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 21 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

Age: 18Years - 80Years

All Genders

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)

Research Team

Nestor Tomycz, MD

Alexander Yu, MD

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