Cervical Arthroplasty Cost Effectiveness Study (CACES)

NCT04623593 | Recruiting DMC

• 1 other identifier: NL72534.096.20
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Radiculopathy, Cervical; Myelopathy Cervical; Myelopathy, Compressive; Radiculopathy, Cervical Region; Radiculopathy; in Spondylosis; Radiculopathy; in Intervertebral Disc Disorder; Myelopathy Neurological; Myelopathy Due to Spondylosis; Cervical Disc Disease; Cervical Disc Herniation; Cervical Disc Degeneration; Cervical Disc Disorder With Myelopathy; Cervical Disc Prolapse With Myelopathy; Cervical Spondylosis; Cervical Fusion; Cervical Disc Disorder With Radiculopathy; Cervical Disc Prolapse With Radiculopathy; Fusion of Spine; Disc Prolapse Cervical

Keywords

Cost-effectivity; Economic evaluation; Health Utility; Randomised controlled trial; RCT; ACDA; ACDF; Anterior cervical discectomy and fusion; Anterior cervical discectomy with arthroplasty; Degenerative cervical myelopathy; Degenerative cervical radiculopathy; ASD; Adjacent Segment Disease; Adjacent Level Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  4 years

• 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.

  4 years

Secondary Outcomes (7)

• CASP

  4 years

• Radiological Outcomes

  1 year

• Neck Disability Index (NDI).

  4 years

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

  4 years

• Hospital Anxiety Depression Scale (HADS)

  4 years

Study Arms (2)

ACDF

ACTIVE COMPARATOR

Anterior cervical discectomy and fusion.

Procedure: ACDF

ACDA

EXPERIMENTAL

Anterior cervical discectomy with arthroplasty.

Procedure: ACDA

Interventions

ACDF PROCEDURE

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.

Also known as: Anterior Cervical Discectomy and Fusion

ACDF

ACDA PROCEDURE

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.

Also known as: Anterior Cervical Discectomy and arthroplasty

ACDA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• In case of myelopathy: symptomatic myelopathy.
• Patients ≥ 18 years of age.

You may not qualify if:

• 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.
• Previous radiotherapy of the cervical spine.
• Metabolic bone disease.
• Inflammatory spinal disease: e.g., Bechterew's disease, Forestier's disease.
• Infection of the cervical spine.

Sponsors & Collaborators

• Valérie Schuermans: lead

Study Sites (1)

Zuyderland Medical Center

Maastricht, Limburg, 6419 PC, Netherlands

RECRUITING

Related Publications (48)

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• Schuermans VNE, Smeets AYJM, Boselie TFM, Candel MJJM, Curfs I, Evers SMAA, Van Santbrink H. Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease - a randomized controlled trial. Trials. 2022 Aug 26;23(1):715. doi: 10.1186/s13063-022-06574-5.

  PMID: 36028916 DERIVED

MeSH Terms

Conditions

Radiculopathy; Spinal Cord Compression; Spinal Cord Diseases; Spondylosis; Klippel-Feil Syndrome

Interventions

Gene Fusion; Arthroplasty

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Central Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Dysostoses; Bone Diseases, Developmental; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Anouk Smeets, MD, PhD, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Schuermans, MD

CONTACT

0031433875001; valerie.schuermans@mumc.nl

Anouk Smeets, MD, PhD

CONTACT

0031433875001; anouk.smeets@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded until one-year after allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: Prospective Single-blind Randomised Controlled Trial with computer randomization in a 1:1 ratio

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 10, 2020
• Study Start: January 17, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

NL (1)