Degenerative Disc Disease
Conditions
Keywords
Tritanium C, Structural Bone Graft, Anterior Cervical Discectomy and Fusion
Brief 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.
Detailed 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 clinic follow-up at 6 and 12 months (3 month visit not required) and imaging that can be used to assess fusion at baseline, 6 and 12 months (3 month imaging not required). If available, NDI and VAS, questionnaires completed during baseline and post-op visits will be collected. This pool of retrospective cohort candidates will be used to match the patients in the prospective cohort to patients treated with structural allograft using a 1:2 ratio. Thus, 40 patients will ultimately be included in the retrospective cohort.
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
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
VB Spine, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
retrospective/prospective observational, two arm study - 40 patients in retrospective cohort (data collection from previous procedure) compared to 20 patients in Prospective cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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) 7. 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)
Exclusion criteria
Patients may not be enrolled in the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the presence of fusion | 3 months post-operatively | Antero-posterior and lateral plain radiographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of sensory deficits | Baseline, 3, 6, and 12 months post-operatively | Yes or no response to: Sensory deficit at the surgical level, sensory deficit at an adjacent level to the surgical level, sensory deficit at a different level to the surgical level, any sensory deficit during follow-up |
| Incidence of motor deficits | Baseline, 3, 6, and 12 months post-operatively | Yes or no response to: Motor deficit at the surgical level, motor deficit at an adjacent level to the surgical level, motor deficit at a different level to the surgical level, any motor deficit |
| Rate of Adverse Events | Day of surgery, 3, 6 and 12 month post-operatively | Adverse Event assessment |
| Neck disability | Baseline, 3, 6, and 12 months post-operatively | Neck Disability Index (NDI): Subjects will designate a statement that best describes their level of disability for each section of the survey. Statements are then ranked from 0-5, where 0 is a better outcome and 5 is a worse outcome. All rankings are totaled for a final score. |
| Neck and arm pain | Baseline, 3, 6, and 12 months post-operatively | Visual Analog Scale (VAS) for neck and arm pain: Subjects will designate a score to represent their pain from 0 to 10. 0 is indicative of no pain and 10 is indicative of the worst possible pain. |
Countries
United States
Contacts
CONTACTNestor Tomycz, MD
CONTACTAlexander Yu, MD
PRINCIPAL_INVESTIGATORNestor Tomycz, MD
Allegheny Health Network
Outcome results
None listed