Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623593
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2020-09-29
Brief Title:
Cervical Arthroplasty Cost Effectiveness Study CACES
Sponsor:
Valérie Schuermans
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
Economic Evaluation of Anterior Cervical Discectomy With Arthroplasty Versus Anterior Cervical Discectomy With Fusion in the Surgical Treatment of Cervical Degenerative Disc Disease a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
CACES
Brief Summary:
To date no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease CDDD The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion ACDF However new complaints of radiculopathy andor myelopathy commonly develop at adjacent levels also known as clinical adjacent segment pathology CASP It remains unknown to what extent kinematics surgery-induced fusion and natural history of disease play a role in its development Anterior cervical discectomy with arthroplasty ACDA is thought to reduce the incidence of CASP by preserving motion in the operated segment ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF However preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term
In this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 11 ratio Adult patients with single- or multi-level CDDD and symptoms of radiculopathy andor myelopathy will be included The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective Secondary objectives are the differences in clinical and radiological outcomes between the two techniques as well as the qualitative process surrounding anterior decompression surgery All outcomes will be measured at baseline and every 6 months till 4 years postoperatively
High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking to date no prospective trials from a societal perspective exist Considering the ageing of the population and the rising healthcare costs the need for a solid clinical cost-effectiveness trial addressing this question is high
In this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 11 ratio Adult patients with single- or multi-level CDDD and symptoms of radiculopathy andor myelopathy will be included The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective Secondary objectives are the differences in clinical and radiological outcomes between the two techniques as well as the qualitative process surrounding anterior decompression surgery All outcomes will be measured at baseline and every 6 months till 4 years postoperatively
High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking to date no prospective trials from a societal perspective exist Considering the ageing of the population and the rising healthcare costs the need for a solid clinical cost-effectiveness trial addressing this question is high
Detailed Description:
Cervical degenerative disc disease CDDD is the degeneration of a cervical intervertebral disc andor the adjoining vertebral bodies resulting in clinical symptoms of cervical radiculopathy myelopathy myeloradiculopathy and axial pain The incidence of degenerative pathologies is significantly increasing as the population of elderly is rising Currently generalized spinal disc degeneration occurs in more than 90 of adults past the 5th decade of lifeThis age group now represents 328 of the population in Europe and is projected to reach 406 by 2050 In the next 20 years a significant increase in anterior cervical decompression surgeries is predicted in those aged 45-54 mainly affecting the working population Complaints of radiculopathy andor myelopathy lead to restrictions in daily life and loss of professional capability resulting in absenteeism Societal healthcare costs are therefore significantly affected by CDDD The healthcare costs are driven up further when patients require surgical treatment in combination with associated hospitalization and rehabilitation To date no consensus exists on which anterior surgical technique is more cost-effective to treat CDDD with radiculopathy andor myelopathy
One of the most common procedures for treating patients with single- or multilevel CDDD is anterior cervical discectomy with fusion ACDF ACDF results in fusion in 95-100 The primary goal of ACDF is the relief of symptoms of radiculopathy andor myelopathy through decompression of neural structures Fusion in itself is not a requisite to reach this goal In our center ACDF with stand-alone cages is the standard procedure for CDDD Plate-constructs are only used on indication A common concern regarding ACDF with stand-alone cages is the occurrence of cage subsidence In our retrospective cohort of 673 patients only 1 patient required additional surgery due to subsidence 015 unpublished data Axial pain alone is not considered an indication for surgical treatment Good short-term clinical results are achieved for both radiculopathy and myelopathy Clinical results are independent from the technique used and independent from occurrence of fusion However patient-reported satisfaction gradually decreases in the years following surgery This is thought to be the consequence of the development of new complaints due to degenerative changes at a segment adjacent to the site of the index surgery also known as adjacent segment pathology ASP
A recent consensus proposes a distinct definition of radiologic adjacent segment pathology RASP and clinical adjacent segment pathology CASP CASP occurs at an estimated cumulative rate of 16 to 42 per year after ACDF however a wide variety in incidence is reported in literature About 50-75 of the patients that develop CASP require additional adjacent segment surgery In our retrospective cohort we observed a rate of 21 CASP per year with an additional adjacent segment surgery rate of 15 per year Moreover we found that half of these patients undergo additional surgery for CASP within 25 years which suggests a peak incidence in the first years following index surgery The underlying mechanism of ASP remains a matter of debate Besides natural degeneration compensation for the loss of motion in the fused segment is thought to cause overstraining of the adjacent segments Altered cervical sagittal alignment is also thought to be of importance in the accelerated development of CASP Higher rates of CASP are observed after ACD concomitant with an increased segmental kyphosis at the index level Unlike ACD ACDF with plate-constructs restore cervical sagittal lordosis However a higher rate of ASP is observed in those with plate-constructs in comparison to ACDF with stand-alone cages The higher rate of ASP after ACDF with plate-constructs might be explained by strain on the adjacent segments by the plate or more extensive surgical preparation for installing the plate increasing the chance on destruction of the adjacent level Another contributing factor might be the occurrence of subsidence of the plate-construct into the adjacent segment Disc height at the adjacent segments is found to be significantly decreased in those with plate-constructs which supports this theory It remains unknown to what extent altered cervical motion influences the development of ASP
Anterior cervical discectomy with arthroplasty ACDA was developed to reduce the incidence of CASP by preserving motion in the operated segment Previously conducted research in patients with radiculopathy andor myelopathy has shown no significant differences in clinical or radiological outcomes amongst ACDA and ACDF A meta-analysis found better neurological outcomes in patients with myelopathy after ACDA in contrast to the pre-existing notion that ACDA leads to less favorable outcomes in myelopathy due to micro-trauma caused by preserved mobility Moreover additional adjacent segment surgery rates are significantly lower for ACDA both for single- and multilevel surgeries The difference in additional adjacent segment surgery rates between ACDA and ACDF expands exponentially with a longer-follow-up time ACDA is often discouraged as the implant costs are higher than those for ACDF whilst clinical outcomes are similar However preventing new complaints and additional surgeries due to CASP might be a reason for ACDA to be a more cost-effective technique in the long-term A systematic review of economic evaluations in anterior cervical decompression surgery was conducted by our research group The majority of studies report ACDA to be the most cost-effective technique despite higher implant costs Literature was however strongly heterogeneous and of low quality
In conclusion there is increasing evidence suggesting that ACDA might be the more cost-effective technique because of a reduced risk on CASP and associated additional surgery rates compared to ACDF High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking especially in Europe Therefore the need for a solid clinical cost-effectiveness trial addressing this question is high
One of the most common procedures for treating patients with single- or multilevel CDDD is anterior cervical discectomy with fusion ACDF ACDF results in fusion in 95-100 The primary goal of ACDF is the relief of symptoms of radiculopathy andor myelopathy through decompression of neural structures Fusion in itself is not a requisite to reach this goal In our center ACDF with stand-alone cages is the standard procedure for CDDD Plate-constructs are only used on indication A common concern regarding ACDF with stand-alone cages is the occurrence of cage subsidence In our retrospective cohort of 673 patients only 1 patient required additional surgery due to subsidence 015 unpublished data Axial pain alone is not considered an indication for surgical treatment Good short-term clinical results are achieved for both radiculopathy and myelopathy Clinical results are independent from the technique used and independent from occurrence of fusion However patient-reported satisfaction gradually decreases in the years following surgery This is thought to be the consequence of the development of new complaints due to degenerative changes at a segment adjacent to the site of the index surgery also known as adjacent segment pathology ASP
A recent consensus proposes a distinct definition of radiologic adjacent segment pathology RASP and clinical adjacent segment pathology CASP CASP occurs at an estimated cumulative rate of 16 to 42 per year after ACDF however a wide variety in incidence is reported in literature About 50-75 of the patients that develop CASP require additional adjacent segment surgery In our retrospective cohort we observed a rate of 21 CASP per year with an additional adjacent segment surgery rate of 15 per year Moreover we found that half of these patients undergo additional surgery for CASP within 25 years which suggests a peak incidence in the first years following index surgery The underlying mechanism of ASP remains a matter of debate Besides natural degeneration compensation for the loss of motion in the fused segment is thought to cause overstraining of the adjacent segments Altered cervical sagittal alignment is also thought to be of importance in the accelerated development of CASP Higher rates of CASP are observed after ACD concomitant with an increased segmental kyphosis at the index level Unlike ACD ACDF with plate-constructs restore cervical sagittal lordosis However a higher rate of ASP is observed in those with plate-constructs in comparison to ACDF with stand-alone cages The higher rate of ASP after ACDF with plate-constructs might be explained by strain on the adjacent segments by the plate or more extensive surgical preparation for installing the plate increasing the chance on destruction of the adjacent level Another contributing factor might be the occurrence of subsidence of the plate-construct into the adjacent segment Disc height at the adjacent segments is found to be significantly decreased in those with plate-constructs which supports this theory It remains unknown to what extent altered cervical motion influences the development of ASP
Anterior cervical discectomy with arthroplasty ACDA was developed to reduce the incidence of CASP by preserving motion in the operated segment Previously conducted research in patients with radiculopathy andor myelopathy has shown no significant differences in clinical or radiological outcomes amongst ACDA and ACDF A meta-analysis found better neurological outcomes in patients with myelopathy after ACDA in contrast to the pre-existing notion that ACDA leads to less favorable outcomes in myelopathy due to micro-trauma caused by preserved mobility Moreover additional adjacent segment surgery rates are significantly lower for ACDA both for single- and multilevel surgeries The difference in additional adjacent segment surgery rates between ACDA and ACDF expands exponentially with a longer-follow-up time ACDA is often discouraged as the implant costs are higher than those for ACDF whilst clinical outcomes are similar However preventing new complaints and additional surgeries due to CASP might be a reason for ACDA to be a more cost-effective technique in the long-term A systematic review of economic evaluations in anterior cervical decompression surgery was conducted by our research group The majority of studies report ACDA to be the most cost-effective technique despite higher implant costs Literature was however strongly heterogeneous and of low quality
In conclusion there is increasing evidence suggesting that ACDA might be the more cost-effective technique because of a reduced risk on CASP and associated additional surgery rates compared to ACDF High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking especially in Europe Therefore the need for a solid clinical cost-effectiveness trial addressing this question is high
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