Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545983
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2020-07-28
Brief Title:
Long-term Follow-up Motion Analysis of ACD Versus ACDA
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
Long-term Follow-up of Movement of the Cervical Spine After Anterior Cervical Discectomy ACD or Anterior Cervical Discectomy With Arthroplasty ACDA
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 parametersendpoints
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 Odoms 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
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 parametersendpoints
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 Odoms 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 discs andor 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 23 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 eg 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 56 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 participants78 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 n12 and ACD n12 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
Although the term physiological motion is commonly used a proper definition has been lacking for a long time Segmental range of motion sROM eg 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 56 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 participants78 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 n12 and ACD n12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None