Clinical trial NCT03028402: Adjacent Segment Mechanics in Cervical Arthrodesis Patients
Official title: Adjacent Segment Mechanics in Cervical Arthrodesis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Degeneration
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be between 21 and 60 years of age and will be scheduled to undergo single-level or two-level anterior cervical discectomy and fusion (ACDF) at the C56, C67, C456 or C567 levels. Indications for surgical intervention will be progressive symptoms refractory to conservative treatment for myelopathy, radiculopathy, or myeloradiculopathy resulting from degenerative spondylosis, symptomatic cervical disc herniation, or symptomatic disc degeneration.

Brief summary: 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.

Detailed description: 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:

1. the natural history of the adjacent disc;
2. disruption of the adjacent segment anatomy due to the initial surgery; and
3. biomechanical stress on the adjacent level following the fusion.

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.

Eligibility criteria: Inclusion Criteria:

* Patients must agree to return for all follow-up visits and provide informed consent.
* Control subjects will be asymptomatic, with no injury or disease that will interfere with spine function, such as previous spine surgery or trauma.

Exclusion Criteria:

* Participants will have no other injury or disease that will interfere with spine function, such as previous spine surgery or trauma
* Individuals who have been previously clinically diagnosed with poor bone quality and those who do not intend to stay in the Pittsburgh area for a period of at least 3 years post-surgery will be excluded.
* Females who are pregnant or plan to be pregnant within 3 years of surgery will be excluded.

Primary outcomes:
measure: Kinematics
timeFrame: pre-surgery to 3 years post-surgery
measure: Iatrogenic factors
timeFrame: pre-surgery to 3 years post-surgery
measure: Kinematics
timeFrame: pre-surgery to 3 years post-surgery
measure: Kinematics
timeFrame: pre-surgery to 3 years post-surgery
measure: Arthrokinematics
timeFrame: pre-surgery to 3 years post-surgery
measure: Arthrokinematics
timeFrame: pre-surgery to 3 years post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Biodynamics Lab
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: William Anderst, PhD
role: PRINCIPAL_INVESTIGATOR
References: