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ACDF Using Structural Allograft vs. Tritanium C

NCT04388332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-14

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Stryker Spine

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Nestor Tomycz, MD · Allegheny Health Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388332 on ClinicalTrials.gov