ACDF Using Structural Allograft vs. Tritanium C

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Procedure: Structural allograft; Device: Tritanium C

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Yu, MD; Phone Number: 412-359-6200; Email: alexander.yu@ahn.org
• Study Contact Backup: Name: Nestor Tomycz, MD; Phone Number: 412-359-6200; Email: nestor.tomycz@ahn.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

The study population sample will be selected from Allegheny General Hospital.

Description

Inclusion Criteria:

1. Males or females ≥18 years of age, ≤ 80 years of age
2. Subject is skeletally mature
3. Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc
4. Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids
5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent (Prospective study)
6. Subjects that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study)
7. 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:

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

1. Presence of an infection systemic or local
2. Presence of marked local inflammation
3. 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
4. Use of bone growth stimulator
5. Subject has prior fusion at the levels to be treated
6. Subject has any neuromuscular deficit
7. Subject has any condition of senility, mental illness, or substance abuse
8. Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery in the judgement of the PI
9. 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.
10. BMI≥40 kg/m2
11. Subject uses chronic corticosteroids
12. Subjects with current active psychiatric diagnosis or a personality disorder likely to interfere with the study
13. Subjects who smoke and do not plan to quit
14. Mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
15. Subject has any open wounds
16. Subject has inadequate tissue coverage over the operative site
17. Subject may be sensitive to titanium materials
18. Subject is missing 6 and/or 12 month clinical or radiographic follow-up (Retrospective study)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
Experimental: Prospective; 20 patients who are receiving Tritanium C as standard of care.	Device: Tritanium 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 is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the presence of fusion	Antero-posterior and lateral plain radiographs	3 months post-operatively
Time to the presence of fusion	Antero-posterior and lateral plain radiographs	6 months post-operatively
Time to the presence of fusion	Antero-posterior and lateral plain radiographs	12 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	Baseline, 3, 6, and 12 months post-operatively
Rate of Adverse Events	Adverse Event assessment	Day of surgery, 3, 6 and 12 month post-operatively

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: Stryker Spine
• Investigators: Principal Investigator: Nestor Tomycz, MD, Allegheny Health Network

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Anterior Cervical Discectomy and Fusion; Tritanium C; Structural Bone Graft
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: Stryker IIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No