ACDF Using Structural Allograft vs. Tritanium C

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT04388332
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Aug 20, 2020
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Allegheny Health NetworkPittsburghPennsylvania15212
Sarah Kimutis
[email protected]
AHN Clinical Trial Contact Clinical Trial Contact
[email protected]
Nestor Tomycz, MD (PRINCIPAL_INVESTIGATOR)
Alexander Yu, MD (SUB_INVESTIGATOR)
Gary Schmidt, MD (SUB_INVESTIGATOR)
Daniel Altman, MD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
Allegheny Health Network· Pittsburgh, PA

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