Degenerative Disc DiseaseNCT04388332
ACDF Using Structural Allograft vs. Tritanium C
A study testing Structural allograft and Tritanium C in people with Degenerative Disc Disease, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Structural allograft and Tritanium C
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Sarah Kimutis, sarah.kimutis@ahn.org
AHN Clinical Trial Contact Clinical Trial Contact, clinicaltrials@ahn.org
About this study
Official title: Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C
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
- Degenerative Disc Disease
- Being tested
- Structural allograft, Tritanium C
- Keywords
- Tritanium C, Structural Bone Graft, Anterior Cervical Discectomy and Fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural allograftProcedure or surgery
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
Tritanium CDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Active comparator | 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. Receives: Procedure: Structural allograft |
| Prospective | Experimental | 20 patients who are receiving Tritanium C as standard of care. Receives: Device: Tritanium C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Measured: 3 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Measured: 6 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Measured: 12 months post-operatively
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, 3, 6, and 12 months post-operatively
Rate of Adverse Events
Adverse Event assessment
Measured: Day of surgery, 3, 6 and 12 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start20 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- retrospective/prospective observational, two arm study - 40 patients in retrospective cohort (data collection from previous procedure) compared to 20 patients in Prospective cohort
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- VB Spine, LLC
- Responsible party
- Principal investigator, Nestor Tomycz, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Nestor Tomycz, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388332
- Sponsor's protocol ID
- Stryker IIT
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C
- ClinicalTrials.gov ID
- NCT04388332
- Acronym / sponsor ID
- Stryker IIT
- Conditions
- Degenerative Disc Disease
- Keywords
- Tritanium C, Structural Bone Graft, Anterior Cervical Discectomy and Fusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- VB Spine, LLC
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- retrospective/prospective observational, two arm study - 40 patients in retrospective cohort (data collection from previous procedure) compared to 20 patients in Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Retrospective | Active comparator | Procedure: Structural allograft40 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. |
| Prospective | Experimental | Device: Tritanium C20 patients who are receiving Tritanium C as standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural allograftSubjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips | Procedure or surgery | Retrospective |
| Tritanium CSubjects 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 | Device | Prospective |
Primary outcome
Time to the presence of fusion
Time frame: 3 months post-operatively
Antero-posterior and lateral plain radiographs
Time to the presence of fusion
Time frame: 6 months post-operatively
Antero-posterior and lateral plain radiographs
Time to the presence of fusion
Time frame: 12 months post-operatively
Antero-posterior and lateral plain radiographs
5 secondary outcomes
Neck disability
Time frame: Baseline, 3, 6, and 12 months post-operatively
Neck and arm pain
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of sensory deficits
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of motor deficits
Time frame: Baseline, 3, 6, and 12 months post-operatively
Rate of Adverse Events
Time frame: Day of surgery, 3, 6 and 12 month post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nestor Tomycz, MD principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural allograft and Tritanium C in people with Degenerative Disc Disease, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nestor Tomycz, MD (412-359-6200, nestor.tomycz@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the presence of fusion (time frame: 3 months post-operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.