ACDF Using Structural Allograft vs. Tritanium C

NCT ID: NCT04388332

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Structural allograft

Intervention Type: PROCEDURE

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

Prospective

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

Group Type: EXPERIMENTAL

Tritanium C

Intervention Type: 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

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

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Spine

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Nestor Tomycz

Assistant Professor, Department of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nestor Tomycz, MD

Role: PRINCIPAL_INVESTIGATOR

Allegheny Health Network

Locations

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nestor Tomycz, MD

Role: CONTACT

nestor.tomycz@ahn.org

412-359-6200

Alexander Yu, MD

Role: CONTACT

alexander.yu@ahn.org

412-359-6200

Facility Contacts

Sarah Kimutis

Role: primary

sarah.kimutis@ahn.org

AHN Clinical Trial Contact Clinical Trial Contact

Role: backup

clinicaltrials@ahn.org

Other Identifiers

Stryker IIT

Identifier Type: -

Identifier Source: org_study_id