Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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.
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…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- ProcedureStructural allograft
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
- DeviceTritanium 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
Location
- Allegheny Health NetworkPittsburgh, Pennsylvania