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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
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
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
RECRUITINGTime to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 3 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 6 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 12 months post-operatively
Neck disability
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.
Time frame: Baseline, 3, 6, and 12 months post-operatively
Neck and arm pain
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.
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of sensory deficits
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
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of motor deficits
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
Time frame: Baseline, 3, 6, and 12 months post-operatively
Rate of Adverse Events
Adverse Event assessment
Time frame: Day of surgery, 3, 6 and 12 month post-operatively
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