RecruitingNCT04388332Updated Aug 31, 2026

ACDF Using Structural Allograft vs. Tritanium C

An interventional study of Structural allograft and Tritanium C in Degenerative Disc Disease, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Non-randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

Retrospective Cohort: A maximum of 200 patients that received one or two level ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips at AHN in the past will retrospectively be screened for inclusion into a pool of potential candidates for the retrospective cohort. Patients will be included in this preliminary pool if the following information are available: age (at surgery), sex, body mass index (at surgery), no smoking at baseline, number of levels operated on, which specific levels were operated on, standard of care clinic follow-up at 6 and 12 months (3 month visit not required) and imaging that can be used to assess fusion at baseline, 6 and 12 months (3 month imaging not required). If available, NDI and VAS, questionnaires completed during baseline and post-op visits will be collected.

This pool of retrospective cohort candidates will be used to match the patients in the prospective cohort to patients treated with structural allograft using a 1:2 ratio. Thus, 40 patients will ultimately be included in the retrospective cohort.

Conditions studied

Degenerative Disc Disease

Browse trials for

Intervertebral Disc Degeneration 463

Keywords

Tritanium C
Structural Bone Graft
Anterior Cervical Discectomy and Fusion

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

Patients may not be enrolled in the study if any of the following exclusion criteria are present:

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)

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Active comparator
Retrospective
40 patients that received one or two level ACDF structural allograft with plates with autograft and /or allograft comprised of cancellous and/or corticocancellous bone chips.
Procedure: Structural allograft
Experimental
Prospective
20 patients who are receiving Tritanium C as standard of care.
Device: Tritanium C

Interventions

ProcedureStructural allograft
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
DeviceTritanium C
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

What researchers measure

Primary outcomes

Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 3 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 6 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 12 months post-operatively

Secondary outcomes

Neck disability
Neck Disability Index (NDI): Subjects will designate a statement that best describes their level of disability for each section of the survey. Statements are then ranked from 0-5, where 0 is a better outcome and 5 is a worse outcome. All rankings are totaled for a final score.
Time frame: Baseline, 3, 6, and 12 months post-operatively
Neck and arm pain
Visual Analog Scale (VAS) for neck and arm pain: Subjects will designate a score to represent their pain from 0 to 10. 0 is indicative of no pain and 10 is indicative of the worst possible pain.
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of sensory deficits
Yes or no response to: Sensory deficit at the surgical level, sensory deficit at an adjacent level to the surgical level, sensory deficit at a different level to the surgical level, any sensory deficit during follow-up
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of motor deficits
Yes or no response to: Motor deficit at the surgical level, motor deficit at an adjacent level to the surgical level, motor deficit at a different level to the surgical level, any motor deficit
Time frame: Baseline, 3, 6, and 12 months post-operatively
Rate of Adverse Events
Adverse Event assessment
Time frame: Day of surgery, 3, 6 and 12 month post-operatively

Study locations

1 of 1 sites recruiting

Allegheny Health Network
Pittsburgh, Pennsylvania 15212, United States
- Sarah Kimutis · Contact · sarah.kimutis@ahn.org
- AHN Clinical Trial Contact Clinical Trial Contact · Contact · clinicaltrials@ahn.org
- Nestor Tomycz, MD · Principal investigator
- Alexander Yu, MD · Sub investigator
- Gary Schmidt, MD · Sub investigator
- Daniel Altman, MD · Sub investigator
Recruiting

Registry details

Key details

Study ID: NCT04388332
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators: VB Spine, LLC
Responsible party: Nestor Tomycz (Assistant Professor, Department of Neurosurgery, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)) — Principal investigator
First posted: May 14, 2020
Start date: Aug 20, 2020
Primary completion: Dec 2026 (estimated)
Completion: Dec 2026 (estimated)
Last update: Aug 31, 2026

Study contacts

Nestor Tomycz, MD

Contact

nestor.tomycz@ahn.org

412-359-6200

Alexander Yu, MD

Contact

alexander.yu@ahn.org

412-359-6200

Nestor Tomycz, MD

principal investigator · Allegheny Health Network

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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