Comparison of Clinical Outcomes Following ACDF with Instrumentation Using Structural Allograft Vs. Tritanium C

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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)

• 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)

Locations
United States
Pennsylvania
Allegheny Health Network
RECRUITING
Pittsburgh
Contact Information
Primary
Nestor Tomycz, MD
nestor.tomycz@ahn.org
412-359-6200
Backup
Alexander Yu, MD
alexander.yu@ahn.org
412-359-6200
Time Frame
Start Date: 2020-08-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators: Stryker Spine

This content was sourced from clinicaltrials.gov

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