Cost-effectiveness of posterior cervical foraminotomy(FOR) versus anterior cervical discotomy with fusion (ACDF) for cervical soft/osteophytic disc disease. A randomized controlled multicenter study. FACET study (Foraminotomy Acdf Cost-Effectiveness Trial)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 308

Inclusion Criteria

- Patient has sufficient mastery of the Dutch language to fill out the questionnaires.
- Age between 18 and 80 years.
- Cervical foraminal stenosis causing monoradiculopathy of C4, C5, C6, or C7 and requiring decompression of 1neuroforamen. Foraminal stenosis due to a soft disc component is defined as: 2/3 of the total discal component is located intraforaminally and a maximum of 1/3 of the total discogenic component is located medially, within the spinal canal. Radiculopathy is defined as pain, paralysis or paresthesia in corresponding nerve root distribution areas of C4, C5, C6,or C7,and must include at least arm or shoulder pain with minimum of 30 mm on a 100 mm visual analog scale.
- No response to conservative treatment for eight weeks or presence of progressive symptoms or signs of nerve root compression in the face of conservative treatment.
- Soft disc/Spondylitic foraminal stenosis (determined by MRI and CT and/or right or left oblique X-ray of the cervical spine) at the treatment level correlating to primary symptoms.
- Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
- Signed and dated informed consent document prior to any study-related procedures.

Exclusion Criteria

- Multisegmental CRS.
- Median located disc protrusion or osteophytic protrusion.
- Foraminal compression of C8.
- Spinal cord compression with clinical myelopathy.
- Radiological myelopathy.
- History of cervical spine surgery.
- Obesity WHO class II or higher (BMI >= 35).
- Osteoporosis / chronic use of corticosteroïds.
- ASA 4 and 5 patients.
- Incapability to speak and write the Dutch language
- Pregnancy
- Active malignancy
- Abundant use of alcohol, drugs, narcotics and recreational drugs.
- Contra-indications for anesthesia or surgery
- Patient has used another investigational drug or device within the 30 days prior to surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction of cervical radicular pain measured by the ODOM criteria (4 point<br /><br>Likert scale) and VAS arm pain.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes include Work Ability (Work Ability Index, single item),<br /><br>Quality of Life (Euroqol-5D), Neck Pain (VAS), Neck disability index(NDI),<br /><br>Complications and Productivity related costs(iPCQ) and medical costs(IMCQ).</p><br>