ACDF Using Structural Allograft vs. Tritanium C

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Presence of an infection systemic or local

Presence of marked local inflammation

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

Use of bone growth stimulator

Trial design

Treatments tested in this trial

  • Structural allograft
  • Tritanium C

Treatment groups

60 Participants
are divided into 2 treatment groups