Intervertebral Disc DegenerationNCT03028402
Adjacent Segment Mechanics in Cervical Arthrodesis Patients
An observational study of Intervertebral Disc Degeneration, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervertebral Disc Degeneration
- What is being tested?
- C5-C6 arthrodesis
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Biodynamics Lab
Pittsburgh, Pennsylvania, 15203
About this study
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.
Read the 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:
- the natural history of the adjacent disc;
- disruption of the adjacent segment anatomy due to the initial surgery; and
- 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.
- Conditions
- Intervertebral Disc Degeneration
- Being tested
- C5-C6 arthrodesis
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C5-C6 arthrodesisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Controls | Individuals who have no history of neck pain, trauma or surgery, similar in age and sex to the surgical patients | |
| C5-C6 arthrodesis | Patients scheduled to undergo C5-C6 anterior cervical arthrodesis Receives: Procedure: C5-C6 arthrodesis | |
| C6-C7 arthrodesis | Patients scheduled to undergo C6-C7 anterior cervical arthrodesis Receives: Procedure: C5-C6 arthrodesis | |
| C4-C5-C6 arthrodesis | Patients scheduled to undergo C4-C5-C6 anterior cervical arthrodesis Receives: Procedure: C5-C6 arthrodesis | |
| C5-C6-C7 arthrodesis | Patients scheduled to undergo C5-C6-C7 anterior cervical arthrodesis Receives: Procedure: C5-C6 arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics
range of motion (ROM) in degrees
Measured: pre-surgery to 3 years post-surgery
Iatrogenic factors
adjacent segment disc height and sagittal alignment; graft height, plate placement
Measured: pre-surgery to 3 years post-surgery
Kinematics
The helical axis of motion (HAM)
Measured: pre-surgery to 3 years post-surgery
Kinematics
The continuous 3D intervertebral kinematics (translations and rotations).
Measured: pre-surgery to 3 years post-surgery
Arthrokinematics
Disc deformation
Measured: pre-surgery to 3 years post-surgery
Arthrokinematics
Facet joint capsule deformation
Measured: pre-surgery to 3 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startApr 2016
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Anderst, University of Pittsburgh
- Investigators
- William Anderst, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028402
- Sponsor's protocol ID
- STUDY19070070
- Status last verified
- Sep 2024
- First submitted
- 10 Feb 2016
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjacent Segment Mechanics in Cervical Arthrodesis Patients
- ClinicalTrials.gov ID
- NCT03028402
- Acronym / sponsor ID
- STUDY19070070
- Conditions
- Intervertebral Disc Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the natural history of the adjacent disc;
- disruption of the adjacent segment anatomy due to the initial surgery; and
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Controls | – | –Individuals who have no history of neck pain, trauma or surgery, similar in age and sex to the surgical patients |
| C5-C6 arthrodesis | – | Procedure: C5-C6 arthrodesisPatients scheduled to undergo C5-C6 anterior cervical arthrodesis |
| C6-C7 arthrodesis | – | Procedure: C5-C6 arthrodesisPatients scheduled to undergo C6-C7 anterior cervical arthrodesis |
| C4-C5-C6 arthrodesis | – | Procedure: C5-C6 arthrodesisPatients scheduled to undergo C4-C5-C6 anterior cervical arthrodesis |
| C5-C6-C7 arthrodesis | – | Procedure: C5-C6 arthrodesisPatients scheduled to undergo C5-C6-C7 anterior cervical arthrodesis |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C5-C6 arthrodesisA 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. | Procedure or surgery | C4-C5-C6 arthrodesis, C5-C6 arthrodesis, C5-C6-C7 arthrodesis, C6-C7 arthrodesis |
Primary outcome
Kinematics
Time frame: pre-surgery to 3 years post-surgery
range of motion (ROM) in degrees
Iatrogenic factors
Time frame: pre-surgery to 3 years post-surgery
adjacent segment disc height and sagittal alignment; graft height, plate placement
Kinematics
Time frame: pre-surgery to 3 years post-surgery
The helical axis of motion (HAM)
Kinematics
Time frame: pre-surgery to 3 years post-surgery
The continuous 3D intervertebral kinematics (translations and rotations).
Arthrokinematics
Time frame: pre-surgery to 3 years post-surgery
Disc deformation
Arthrokinematics
Time frame: pre-surgery to 3 years post-surgery
Facet joint capsule deformation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Anderst, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics (time frame: pre-surgery to 3 years post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.