Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990.
K Radhakrishnan, W J Litchy, W M O'Fallon...
https://pubmed.ncbi.nlm.nih.gov/8186959Actively Recruiting
Led by Valérie Schuermans · Updated on 2024-01-25
198
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
Cervical Arthroplasty Cost Effectiveness Study (CACES)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
Zuyderland Medical Center
Maastricht, Limburg, Netherlands, 6419 PC
Actively Recruiting
V
Valérie Schuermans, MD
A
Anouk Smeets, MD, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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