University of Pittsburgh Biodynamics Lab
Pittsburgh, Pennsylvania, 15203, United States
NCT Number: NCT03028402
This study aims to determine to what extent patient-specific factors, iatrogenic factors, and biomechanical factors influence cervical spine mechanics after single-level and two-level arthrodesis.
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Notify Me21 year–60 year
All sexes
Observational
Pittsburgh, Pennsylvania, 15203, United States
The etiology of adjacent segment pathology following cervical fusion remains highly controversial. Adjacent segment disease is believed to result from one or more of the following distinct causes:
The long-term goal of our research is to reduce or prevent symptomatic adjacent segment degeneration in the spine. The overall hypothesis of this study is that adjacent segment kinematics (i.e. translations, rotations, helical axis of motion) and arthrokinematics (i.e. disc deformation and facet joint surface interactions) after ACDF are determined primarily by patient-specific anatomy and iatrogenic factors, and not by increased biomechanical stress due to the fusion.
A prospective longitudinal study is proposed to determine to what extent patient-specific factors (Specific Aim 1), iatrogenic factors (Specific Aim 2), and altered biomechanics (Specific Aim 3) affect dynamic cervical spine function following fusion. Participants will be C56 (n=22) and C67 (n=22) single-level fusion patients, C456 (n=22) and C567 (n=22) two-level fusion patients, and asymptomatic controls similar in age to the fusion patients (n=22). Patients will be tested prior to surgery, one year post-surgery, and three years post-surgery. At each test, participants will complete clinical questionnaires to assess pain and function, and they will perform full range of motion flexion\\extension and axial rotation of the head and cervical spine while biplane radiographs are recorded at 30 images per second. A highly accurate and validated volumetric model-based tracking process and custom data analysis software will be utilized to determine intervertebral kinematics (i.e. translations, rotations, helical axis of motion) and arthrokinematics (i.e. disc deformation and facet joint surface interactions) at each test session.
This prospective study will identify the factors that have the greatest effect on adjacent segment mechanics after cervical fusion. If the hypotheses are confirmed, this will provide support for increased attention to patient-specific factors and surgical technique. Alternatively, if the results indicate that adjacent segment mechanics are influenced primarily by increased stress after arthrodesis, this will provide support for increased attention to the design of motion-sparing devices.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A standard Smith Robinson anterior medial approach to the cervical spine. Vertebral endplates will be prepared by removing the cartilage endplate. Tricortical anterior iliac crest autografts will be harvested with a low-speed oscillating saw. Allografts will be fresh-frozen, vacuum-sealed, nonradiated tricortical grafts. All grafts will be fashioned in a typical Smith-Robinson formation. The motion segment will be distracted approximately 2-mm beyond the graft height before the insertion of each graft. Fusion plate will be contoured to cervical lordosis. Cervical plates will be positioned using surgical midline markers. All rigid anterior plate fixations will be performed using titanium anterior fixed-angle screw systems.
Time frame: pre-surgery to 3 years post-surgery
range of motion (ROM) in degrees
Time frame: pre-surgery to 3 years post-surgery
adjacent segment disc height and sagittal alignment; graft height, plate placement
Time frame: pre-surgery to 3 years post-surgery
The helical axis of motion (HAM)
Time frame: pre-surgery to 3 years post-surgery
The continuous 3D intervertebral kinematics (translations and rotations).
Time frame: pre-surgery to 3 years post-surgery
Disc deformation
Time frame: pre-surgery to 3 years post-surgery
Facet joint capsule deformation
University of Pittsburgh
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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