ACDF Using Structural Allograft vs. Tritanium C

NCT04388332 | Recruiting DMC FDA Device

• 1 other identifier: Stryker IIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease

Keywords

Tritanium C; Structural Bone Graft; Anterior Cervical Discectomy and Fusion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Neck disability

  Baseline, 3, 6, and 12 months post-operatively

• Neck and arm pain

  Baseline, 3, 6, and 12 months post-operatively

• Incidence of sensory deficits

  Baseline, 3, 6, and 12 months post-operatively

• Incidence of motor deficits

  Baseline, 3, 6, and 12 months post-operatively

• Rate of Adverse Events

  Day of surgery, 3, 6 and 12 month post-operatively

Study Arms (2)

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.

Procedure: Structural allograft

Prospective

EXPERIMENTAL

20 patients who are receiving Tritanium C as standard of care.

Device: Tritanium C

Interventions

Structural allograft PROCEDURE

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

Retrospective

Tritanium C DEVICE

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

Prospective

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Stryker Spine: collaborator

Study Sites (1)

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Nestor Tomycz, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nestor Tomycz, MD

CONTACT

412-359-6200; nestor.tomycz@ahn.org

Alexander Yu, MD

CONTACT

412-359-6200; alexander.yu@ahn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurosurgery

Model Details: retrospective/prospective observational, two arm study - 40 patients in retrospective cohort (data collection from previous procedure) compared to 20 patients in Prospective cohort

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: May 14, 2020
• Study Start: August 20, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)