Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04623593

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

Led by Valérie Schuermans · Updated on 2024-01-25

198

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical techniques for treating cervical degenerative disc disease (CDDD), which causes symptoms like radiculopathy and myelopathy. The study compares anterior cervical discectomy with fusion (ACDF), a common surgery that fuses spinal segments, to anterior cervical discectomy with arthroplasty (ACDA), which preserves motion at the operated segment. The main goal is to determine which technique is more cost-effective over the long term, considering both health outcomes and societal costs, as no clear consensus currently exists on this matter. Participants will be randomly assigned to receive either ACDF or ACDA surgery. Both procedures begin with removing the damaged disc through an anterior approach. In ACDF, a cage is implanted to fuse the vertebrae, while in ACDA, a cervical disc prosthesis is placed to preserve motion. These interventions can be performed at a single or multiple spinal levels. Postoperative care includes wound closure and drain placement as needed. During the study, participants will be followed for up to four years with assessments at baseline and every six months. Researchers will collect clinical and radiological data, including measures of neck disability, pain scales, anxiety and depression levels, and neurological function. They will also evaluate the development of clinical adjacent segment pathology (CASP) and perform a process evaluation related to the surgical treatment. The focus is on both the effectiveness and costs associated with each surgical technique from a societal viewpoint.

CONDITIONS

Brief Title

Cervical Arthroplasty Cost Effectiveness Study (CACES)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for anterior cervical decompression surgery.
  • Single- or multilevel cervical degenerative disc disease between C3 and C7.
  • Symptoms of myelopathy, radiculopathy, or myeloradiculopathy.
  • For pure radiculopathy: refractory to at least 6 weeks of conservative therapy.
  • For myelopathy: symptomatic myelopathy.
  • Patients 18 years of age or older.
Not Eligible

You will not qualify if you...

  • 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 such as Bechterew's disease or Forestier's disease.
  • Infection of the cervical spine.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Single surgical procedure

Participants undergo anterior cervical discectomy surgery with either fusion or arthroplasty to treat cervical degenerative disc disease.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 4 years

Participants are followed after surgery to monitor recovery, clinical outcomes, and any complications.

Regular follow-up visits over 4 years

Trial Site Locations

Total: 1 location

1

Zuyderland Medical Center

Maastricht, Limburg, Netherlands, 6419 PC

Actively Recruiting

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Research Team

V

Valérie Schuermans, MD

A

Anouk Smeets, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression.

Michael G Fehlings, Lindsay A Tetreault, K Daniel Riew...

https://pubmed.ncbi.nlm.nih.gov/29164035

What's the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? A randomized controlled trial.

Roland D Donk, André L M Verbeek, Wim I M Verhagen...

https://pubmed.ncbi.nlm.nih.gov/28850600