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Cervical Arthroplasty Cost Effectiveness Study (CACES)

ConditionsRadiculopathy, CervicalMyelopathy CervicalMyelopathy, CompressiveRadiculopathy, Cervical RegionRadiculopathy; in SpondylosisRadiculopathy; in Intervertebral Disc DisorderMyelopathy NeurologicalMyelopathy Due to SpondylosisCervical Disc DiseaseCervical Disc HerniationCervical Disc DegenerationCervical Disc Disorder With MyelopathyCervical Disc Prolapse With MyelopathyCervical SpondylosisCervical FusionCervical Disc Disorder With RadiculopathyCervical Disc Prolapse With RadiculopathyFusion of SpineDisc Prolapse Cervical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorValérie Schuermans

About this trial

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 and/or 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 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indication for anterior cervical decompression surgery.

Single- or multilevel CDDD between C3 and C7.

Symptoms of myelopathy, radiculopathy, or myeloradiculopathy.

In case of pure radiculopathy: refractory to at least 6 weeks of conservative therapy.

Disqualifiers

Indication for (additional) posterior surgical approach.

Indication for additional stabilization of the pathological segment by a plate.

Previous ventral surgery of the cervical spine.

Traumatic origin of the compression.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACDF

    Procedure/Surgery

    Standard operative treatment for anterior cervical discectomy. Through a right or left-sided approach the disc space contents are resected. The endplates are prepared with curettes and the disc space contents are removed. The posterior longitudinal ligament is opened. The dura is visualized to ensure adequate decompression. A cage is implanted in the disc space. The disc removal and cage implantation can be performed at a single level or at multiple levels. The wound is closed in layers, after a prevertebral wound drain is placed.

  • ACDA

    Procedure/Surgery

    The start of the procedure is the same as in the ACDF group. After the discectomy, a cervical disc prosthesis is placed in the disc space instead of a cage, in accordance with the manufacturer's protocol for implantation and endplate preparation. The disc removal and arthrodesis implantation can be performed at a single level or at multiple levels. Wound closure is similar to the ACDF procedure.

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: ACDFActive comparator 1 intervention
Group B: ACDAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Costs

Costs will be determined from a societal perspective. Validated cost questionnaires for societal costs, including medical consumption, both paid and unpaid loss of productivity for patients. : * Productivity Cost Questionnaire (iPCQ) for measuring productivity loss for work loss (paid and unpaid). Consists of 7 questions. * the Medical Consumption Questionnaire (iMCQ) for measuring medical consumption, especially designed for the Dutch health care environment. Consists of 14 questions. Informal caregivers will be asked to fill out the Limited Valuation of Informal Care Questionnaire (iVICQ): * informal care giver (ICG) productivity loss for work loss (paid and unpaid) * Care-related Quality of Life instrument (CarerQol-7D). * The Self-Rated Burden scale (SRB), a horizontal 'visual-analog scale' to determine the subjective burden of the caregiver on a scale from 0 (not heavy) to 10 (very heavy).

Time frame
4 years
2

Effectiveness

In the CUA, the Incremental Cost-Effectiveness Ratio (ICER) will be expressed as the incremental costs per QALY. Quality Adjusted Life Years (QALYs) will be determined by Generic Quality of Life assessed based on the EuroQol utility scores (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Time frame
4 years

Secondary outcomes

1

CASP

The rate of clinical adjacent segment pathology and associated additional surgeries will be assessed.

Time frame
4 years
2

Radiological Outcomes

At 3 time points; pre-operatively, directly post-operative and one-year post-operative. * Pre-operative imaging will assess baseline degeneration according to the Kellgren-Lawrence Score, cervical sagittal alignment and baseline disc height. Moreover, a full sagittal spine X-ray will be made to assess pre-operative global balance according to the odontoid-hip axis. * Post-operative: A standard cervical spine X-ray to assess the position of the implant, subsidence and cervical sagittal alignment. * 1 year post-operative cervical spine X-rays will be made. A standard cervical spine X-ray will be made to assess fusion, cage subsidence, adjacent segment degeneration (KS), adjacent segment disc height and alignment. A flexion and extension X-ray will be made to assess movement.

Time frame
1 year
3

Neck Disability Index (NDI).

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 question is scored on a 0-5 scale, where 0 is no disability and 5 is the maximal disability possible

Time frame
4 years
4

Visual Analogue Scale (VAS) for neck and arm pain.

Visual Analogue Scale (VAS) for neck and arm pain. Neck and arm pain are assessed separately on a horizontal 10 cm visual scale, varying from 0 cm (no pain) to 10 cm (worst pain imaginable)

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Valérie Schuermans

Lead sponsor

Zuyderland Medisch Centrum

Sponsor institution

Source ClinicalTrials.gov
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