Recruiting

Structural Allograft vs. Tritanium C

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT04388332

Conditions

Degenerative Disc Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Structural allograft

Tritanium C

Study Details

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

Study ID

NCT04388332

Start date

Aug 20, 2020

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

experimental: Prospective

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

Interventions

Structural allograft

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

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

Primary outcome measure

  • Time to the presence of fusion [ Time Frame: 3 months post-operatively ]
  • Time to the presence of fusion [ Time Frame: 6 months post-operatively ]
  • Time to the presence of fusion [ Time Frame: 12 months post-operatively ]

Central Contacts and Locations

Central contacts

Locations

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

AHN Clinical Trial Contact Clinical Trial Contact

clinicaltrials@ahn.org

Principal Investigator:

Nestor Tomycz, MD

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-08-31.