Cervical MyelopathyNCT04545983
Long-term Follow-up Motion Analysis of ACD Versus ACDA
A study testing Motion Analysis in people with Cervical Myelopathy and Cervical Radiculopathy, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Myelopathy, Cervical Radiculopathy, Spinal Stenosis
- What is being tested?
- Motion Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Feb 2022to 25 Oct 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI.
- Aged 18-55 years.
- Able to actively perform flexion/extension movement.
- Able to read the information form and sign IC.
- For this long-term follow-up study, inclusion criteria are:
- All participants of previous RCT
Show all 14Show fewer
- Able to perform flexion/extension movement of the cervical spine
- Signed IC.
- Patients were excluded in the previous RCT based on the following criteria, and will now be excluded based on the same criteria:
- Ongoing or active infection.
- Previous or actual tumorous processes in the cervical region.
- Pregnancy.
- Previous radiation therapy in the cervical region.
- Not being able to speak Dutch.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Movement of the Cervical Spine After Anterior Cervical Discectomy (ACD) or Anterior Cervical Discectomy With Arthroplasty (ACDA)
Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment.
Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA.
Read more
Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial.
Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery.
Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made.
Main study parameters/endpoints:
The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.
Read the detailed description
Cervical degenerative disc disease (CDDD) results from degeneration of cervical intervertebral disc(s) and/or the adjoining vertebral bodies. This causes clinical symptoms of cervical myelopathy, radiculopathy or myeloradiculopathy. Surgical treatment can be an option if non-surgical treatment options provide insufficient relief. The standard surgical technique for treating single or multilevel CDDD is anterior cervical discectomy, either without (ACD) or with fusion (ACDF). Both ACD and ACDF have good short-term clinical results in 90-100% of patients. Both techniques also have a high rate of fusion, respectively 70-80% and 95-100% 1. After 7-20 years, patient satisfaction slowly drops to 68-96% 2. The reason for this decline is thought to be due to the development of adjacent segment disease (ASDis). This is defined as the development of new complaints of radiculopathy or myelopathy due to degeneration one level above or below the previously operated segment. This occurs in approximately 25% of patients during 10 years follow-up and more than 2/3 of these patients need additional surgery 3. The underlying mechanism is thought to be compensation of loss of motion in the fused segment, resulting in overstraining of the adjacent segments 4. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment.
Although the term 'physiological motion' is commonly used, a proper definition has been lacking for a long time. Segmental range of motion (sROM, e.g. the amount of sagittal rotation in a segment between maximal flexion and maximal extension position of the entire cervical spine) is most commonly used to study motion. SROM, however, suffers from large intra- and interindividual variability 5,6. Therefore, in the lower cervical spine, Boselie et al have recently described a consistent sequence of segmental contribution in sagittal rotation during flexion and extension in 80-90% of 20 healthy participants7,8. The normal sequence of segmental contributions in the lower cervical spine during the second half of extension was C4-C5 followed by C5-C6, and then C6-C7.
Moreover, Boselie et al performed a randomized controlled trial (RCT) to compare the presence of this physiological motion pattern and clinical outcomes for ACDA (n=12) and ACD (n=12) patients. Before the randomization 3 patients were operated in a pilot group (all with ACDA), so in total 27 patients with CDDD and radiculopathy were operated. In both groups 10 patients were available for follow-up at one year and fusion rate was 0% in the ACDA group and 70% in the ACD group. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This is the first method described which can reliably differentiate between normal or abnormal movement of the cervical spine in an individual subject. There were no differences in patient reported outcome measures, however the study population was small. These data have been submitted but not been published yet since follow-up duration is considered too short for most journals. The primary goal when performing the study was to analyze the sequence of segmental contribution of motion for which a follow-up duration of one year seemed appropriate. However, the expected advantage of the ACDA lies in the long-term, since it should lead to less ASDis by preserving physiological motion in the operated segment. Therefore, longer follow-up is needed to be able to determine if this physiological motion pattern remains present in the ACDA group at the long term. In the RCT performed by Boselie et al, the first patient was operated in December 2007 and the last patient in September 2014. At this moment the follow-up duration is therefore 6 to almost 13 years. By using the same method for analyzing the sequence of segmental contribution of motion in the cervical spine 8, the investigators want to analyze these 27 patients again in the long-term (at an average follow up of 9 years).
The investigators hypothesize that normal motion of the cervical spine will also be preserved by ACDA at the long-term, whereas ACD shows a decline in motion due to the induced fusion at the operated segment. As a consequence, the investigators expect ACDA to induce a lower risk on developing ASDis and thus re-operations.
- Conditions
- Cervical Myelopathy, Cervical Radiculopathy, Spinal Stenosis, Spinal Disease, Spine Degeneration, Spine Fusion
- Being tested
- Motion Analysis
- Keywords
- Anterior Cervical Discectomy, Anterior Cervical Discectomy with Arthroplasty, ACD, ACDA, Cervical Motion, Long-term Follow-up, Motion Analysis
- Medical subject headings
- Radiculopathy, Spinal Stenosis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion AnalysisOther
Cinematographic recordings will be made. Participants are seated on a crutch, adjustable in height, with their neck, shoulders and head free. Before recordings are made, participants will be instructed to perform the prescribed flexion and extension movement in about 10 seconds with 7 frames per second. Participants are placed on the crutch with their shoulder's perpendicular to the image intensifier to obtain sagittal images from the occiput till C7. As soon as the recording is started, the participant is instructed to move his head in the sagittal plane from maximal extension to maximal flexion, without moving the upper part of the body. It is important that the participants shoulders are kept as low as possible while making the recordings to ensure that all the cervical vertebrae are visible. The movement of the cervical spine should be as fluent as possible to prevent for sudden large rotations and translations between consecutive frames.
| Study group | Role | What they receive |
|---|---|---|
| ACD | Active comparator | In the previously conducted RCT 27 adult patients with an indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI, were included and randomized to undergo ACD or ACDA. Receives: Other: Motion Analysis |
| ACDA | Experimental | In the previously conducted RCT 27 adult patients with an indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI, were included and randomized to undergo ACD or ACDA. Receives: Other: Motion Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion Analysis
The sequence of segmental contributions in sagittal rotation during flexion and extension in the lower cervical spine at the long-term after ACDA or ACD surgery for CDDD will be defined. There will be differentiated between normal or abnormal movement amongst ACD and ACDA.
Measured: 9,5 years average
Level of Degeneration
At the start of the cinematographic recording, one image will be saved as a lateral X-ray of the cervical spine to determine Kellgren's Score (KS).
The KS will be determined by two neurosurgeons and is a scoring method to determine severity of degenerative disc disease, using five gradations:
- Grade 0: absence of degeneration in the disc.
- Grade 1: minimal anterior osteophytosis.
- Grade 2: definite anterior osteophytosis, possible narrowing of the disc space, some sclerosis of the vertebral plates.
- Grade 3: moderate narrowing of the disc space, sclerosis of the vertebral plates, osteophytosis.
- Grade 4: severe narrowing of the disc space, severe sclerosis of the vertebral plates, multiple large osteophytes.
Measured: 9,5 years average
Secondary outcomes (5)
VAS Score
Patients will be asked to indicate the VAS score for neck and arm pain (both left and right) will be asked
Measured: 9,5 years average
NDI
The NDI is a modification of the Oswestry Low Back Pain Disability Index. It is a patient- completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Al the points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means: no activity limitations, 50 points or 100% means complete activity limitation.
Measured: 9,5 years average
SF-36
The SF-36 health survey will be used to assess both mental and physical health from the patient's perspective
Measured: 9,5 years average
Odom's Outcome Criteria
The Odom's Outcome Criteria will be evaluated in all patients. This score was developed to assess clinical outcomes of cervical degenerative disc surgery
Measured: 9,5 years average
New complaints and/or surgeries
Patients will be asked whether they have new complaints of radiculopathy, myelopathy or myeloradiculopathy and whether they underwent a re-operation for these complaints.
Measured: 9,5 years average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start12 Feb 2022
- Primary completion12 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a fundamental research project in which a cohort of previously operated patients will be included. All of these patients were previously operated in the setting of an RCT an underwent ACD or ACDA for CDDD. In the RCT flexion and extension cinematographic recordings of the cervical spine were made before surgery, and at three months and one-year post-operatively. This study investigates the long-term follow-up of this same study population. The average follow-up duration is 9 years (range 6-13 years). We make similar flexion and extension cinematographic recordings to assess the sequence of segmental contributions of the lower cervical spine years after ACD and ACDA surgery for CDDD. The sROM and level of degeneration will be assessed as a secondary outcome. Moreover, the long-term clinical outcomes will be assessed through questionnaires.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henk Van Santbrink, Md, PhD, Professor, Principal investigator, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545983
- Sponsor's protocol ID
- Z2020101
- Status last verified
- May 2021
- First submitted
- 28 Jul 2020
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Movement of the Cervical Spine After Anterior Cervical Discectomy (ACD) or Anterior Cervical Discectomy With Arthroplasty (ACDA)
- ClinicalTrials.gov ID
- NCT04545983
- Acronym / sponsor ID
- Z2020101
- Conditions
- Cervical Myelopathy, Cervical Radiculopathy, Spinal Stenosis, Spinal Disease, Spine Degeneration, Spine Fusion
- Keywords
- Anterior Cervical Discectomy, Anterior Cervical Discectomy with Arthroplasty, ACD, ACDA, Cervical Motion, Long-term Follow-up, Motion Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 11 Sep 2020 (actual)
- 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.
Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment.
Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA.
Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial.
Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery.
Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made.
Main study parameters/endpoints:
The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.
Detailed description
Cervical degenerative disc disease (CDDD) results from degeneration of cervical intervertebral disc(s) and/or the adjoining vertebral bodies. This causes clinical symptoms of cervical myelopathy, radiculopathy or myeloradiculopathy. Surgical treatment can be an option if non-surgical treatment options provide insufficient relief. The standard surgical technique for treating single or multilevel CDDD is anterior cervical discectomy, either without (ACD) or with fusion (ACDF). Both ACD and ACDF have good short-term clinical results in 90-100% of patients. Both techniques also have a high rate of fusion, respectively 70-80% and 95-100% 1. After 7-20 years, patient satisfaction slowly drops to 68-96% 2. The reason for this decline is thought to be due to the development of adjacent segment disease (ASDis). This is defined as the development of new complaints of radiculopathy or myelopathy due to degeneration one level above or below the previously operated segment. This occurs in approximately 25% of patients during 10 years follow-up and more than 2/3 of these patients need additional surgery 3. The underlying mechanism is thought to be compensation of loss of motion in the fused segment, resulting in overstraining of the adjacent segments 4. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment.
Although the term 'physiological motion' is commonly used, a proper definition has been lacking for a long time. Segmental range of motion (sROM, e.g. the amount of sagittal rotation in a segment between maximal flexion and maximal extension position of the entire cervical spine) is most commonly used to study motion. SROM, however, suffers from large intra- and interindividual variability 5,6. Therefore, in the lower cervical spine, Boselie et al have recently described a consistent sequence of segmental contribution in sagittal rotation during flexion and extension in 80-90% of 20 healthy participants7,8. The normal sequence of segmental contributions in the lower cervical spine during the second half of extension was C4-C5 followed by C5-C6, and then C6-C7.
Moreover, Boselie et al performed a randomized controlled trial (RCT) to compare the presence of this physiological motion pattern and clinical outcomes for ACDA (n=12) and ACD (n=12) patients. Before the randomization 3 patients were operated in a pilot group (all with ACDA), so in total 27 patients with CDDD and radiculopathy were operated. In both groups 10 patients were available for follow-up at one year and fusion rate was 0% in the ACDA group and 70% in the ACD group. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This is the first method described which can reliably differentiate between normal or abnormal movement of the cervical spine in an individual subject. There were no differences in patient reported outcome measures, however the study population was small. These data have been submitted but not been published yet since follow-up duration is considered too short for most journals. The primary goal when performing the study was to analyze the sequence of segmental contribution of motion for which a follow-up duration of one year seemed appropriate. However, the expected advantage of the ACDA lies in the long-term, since it should lead to less ASDis by preserving physiological motion in the operated segment. Therefore, longer follow-up is needed to be able to determine if this physiological motion pattern remains present in the ACDA group at the long term. In the RCT performed by Boselie et al, the first patient was operated in December 2007 and the last patient in September 2014. At this moment the follow-up duration is therefore 6 to almost 13 years. By using the same method for analyzing the sequence of segmental contribution of motion in the cervical spine 8, the investigators want to analyze these 27 patients again in the long-term (at an average follow up of 9 years).
The investigators hypothesize that normal motion of the cervical spine will also be preserved by ACDA at the long-term, whereas ACD shows a decline in motion due to the induced fusion at the operated segment. As a consequence, the investigators expect ACDA to induce a lower risk on developing ASDis and thus re-operations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a fundamental research project in which a cohort of previously operated patients will be included. All of these patients were previously operated in the setting of an RCT an underwent ACD or ACDA for CDDD. In the RCT flexion and extension cinematographic recordings of the cervical spine were made before surgery, and at three months and one-year post-operatively. This study investigates the long-term follow-up of this same study population. The average follow-up duration is 9 years (range 6-13 years). We make similar flexion and extension cinematographic recordings to assess the sequence of segmental contributions of the lower cervical spine years after ACD and ACDA surgery for CDDD. The sROM and level of degeneration will be assessed as a secondary outcome. Moreover, the long-term clinical outcomes will be assessed through questionnaires.
| Arm | Type | Receives |
|---|---|---|
| ACD | Active comparator | Other: Motion AnalysisIn the previously conducted RCT 27 adult patients with an indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI, were included and randomized to undergo ACD or ACDA. |
| ACDA | Experimental | Other: Motion AnalysisIn the previously conducted RCT 27 adult patients with an indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI, were included and randomized to undergo ACD or ACDA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- An indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI.
- Aged 18-55 years.
- Able to actively perform flexion/extension movement.
- Able to read the information form and sign IC.
- All participants of previous RCT
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motion AnalysisCinematographic recordings will be made. Participants are seated on a crutch, adjustable in height, with their neck, shoulders and head free. Before recordings are made, participants will be instructed to perform the prescribed flexion and extension movement in about 10 seconds with 7 frames per second. Participants are placed on the crutch with their shoulder's perpendicular to the image intensifier to obtain sagittal images from the occiput till C7. As soon as the recording is started, the participant is instructed to move his head in the sagittal plane from maximal extension to maximal flexion, without moving the upper part of the body. It is important that the participants shoulders are kept as low as possible while making the recordings to ensure that all the cervical vertebrae are visible. The movement of the cervical spine should be as fluent as possible to prevent for sudden large rotations and translations between consecutive frames. | Other | ACD, ACDA |
Primary outcome
Motion Analysis
Time frame: 9,5 years average
The sequence of segmental contributions in sagittal rotation during flexion and extension in the lower cervical spine at the long-term after ACDA or ACD surgery for CDDD will be defined. There will be differentiated between normal or abnormal movement amongst ACD and ACDA.
Level of Degeneration
Time frame: 9,5 years average
At the start of the cinematographic recording, one image will be saved as a lateral X-ray of the cervical spine to determine Kellgren's Score (KS). The KS will be determined by two neurosurgeons and is a scoring method to determine severity of degenerative disc disease, using five gradations: * Grade 0: absence of degeneration in the disc. * Grade 1: minimal anterior osteophytosis. * Grade 2: definite anterior osteophytosis, possible narrowing of the disc space, some sclerosis of the vertebral plates. * Grade 3: moderate narrowing of the disc space, sclerosis of the vertebral plates, osteophytosis. * Grade 4: severe narrowing of the disc space, severe sclerosis of the vertebral plates, multiple large osteophytes.
5 secondary outcomes
VAS Score
Time frame: 9,5 years average
NDI
Time frame: 9,5 years average
SF-36
Time frame: 9,5 years average
Odom's Outcome Criteria
Time frame: 9,5 years average
New complaints and/or surgeries
Time frame: 9,5 years average
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 27 Jan 2023.
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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.
Henk Van Santbrink, Md, PhD, Professor principal investigator
Zuyderland Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion Analysis in people with Cervical Myelopathy and Cervical Radiculopathy, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 14 inclusion and 0 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 27 Jan 2023. 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 Netherlands. 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?
Motion Analysis (time frame: 9,5 years average). The study lists 2 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 27 Jan 2023.