Comparison of cost-effectiveness between two surgical procedures (anterior or posterior decompression) in patients with cervical nerve root entrapment

Disability due to cervical radiculopathy has a significant impact on the patient’s quality of life, particularly because most patients participate in the community’s labour force. Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Currently, there are no evidence-based guidelines on the most appropriate surgical treatment strategy. In the Netherlands, there is a surgeon’s preference for ACDF. However, there is evidence that FOR is as effective as ACDF, has a smaller complication rate and is less expensive. The study objectives of the FACET study are to compare clinical outcome (decrease of radiculopathy in VAS ARM pain and Odom's criteria), complication rates, cost-effectiveness and work absenteeism with a non-inferiority hypothesis of FOR to ACDF.

Timepoint 1: Baseline evaluation after informed consent is signed

- Medical and preoperative history

- Clinical evaluation (signs, symptoms, strength, reflexes)

- Web based patient self-assessment (questionnaires: arm pain VAS, neck pain VAS, WAI, EQ-5D, NDI, iMCQ, iPCQ)



Timepoint 2: Surgical Procedure (FOR or ACDF), following standard care protocol.

- Surgical evaluation report (date, type, antibiotic prophylaxes, level of procedure, instruments, complications and (S)AE’s).

Timepoint 3: Day of discharge

- Clinical evaluation (signs, symptoms, strength, reflexes)

- Odom’s criteria

Timepoint 3.1-3.5: 1 week till 5 weeks after discharge; weekly assessment of arm and neck pain VAS (web based)



Timepoint 4: 6 weeks after operation (± 1 week) (at outpatient clinic)

- Clinical evaluation (signs, symptoms, strength, reflexes)

- Odom’s criteria

- Web based patient self-assessment on pain, quality of life and costs (questionnaires: arm pain VAS, neck pain VAS, WAI, EQ-5D, NDI, iPCQ, iMCQ)

Timepoint 5: 26 weeks after operation (± 2 weeks) (patients do not attend the hospital)

- Web based patient self-assessment on pain, quality of life and costs (questionnaires: arm pain VAS, neck pain VAS, WAI, EQ-5D, NDI, iPCQ, iMCQ)

- Odom’s criteria (patients will be contacted by telephone, by an independent interviewer, to evaluate the ODOM’s criteria)



Timepoint 6: 52 weeks after operation (± 4 weeks) (patients do not attend the hospital)

- Web based patient self-assessment on pain, quality of life and costs (questionnaires: arm pain VAS, neck pain VAS, WAI, EQ-5D, NDI, iPCQ, iMCQ)

- Odom’s criteria (patients will be contacted by telephone, by an independent interviewer, to evaluate the ODOM’s criteria)


Timepoint 7: 78 weeks after operation (± 4 weeks) (patients do not attend the hospital)

- Web based patient self-assessment on pain, quality of life and costs (questionnaires: arm pain VAS, neck pain VAS, WAI, EQ-5D, NDI, iPCQ, iMCQ)

- Odom’s criteria (patients will be contacted by telephone, by an independent interviewer, to evaluate the ODOM’s criteria)



Timepoint 8: 104 weeks after operation (± 4 weeks) (patients do not attend the hospital)

- Web based patient self-assessment on pain, quality of life and costs (questionnaires: arm pain VAS, neck pain VAS, WAI, EQ-5D, NDI, iPCQ, iMCQ)

- Odom’s criteria (patients will be contacted by telephone, by an independent interviewer, to evaluate the ODOM’s criteria)



During the complete study period, adverse events and serious adverse events will be reported.

ACDF technique:

Microsurgical discectomy is performed through a ventral approach described by Smith and Robinson (1958). Procedure can be executed with microscope or loupe magnification. Exploration of the intervertebral disc and removal of bony spurs with a high-speed drill. Removal of the posterior part of the intervertebral space. The posterior ligament is dissected and removed with rongeurs. Subligamentous discal fragments are removed. The proximal part of the neuroforamen is inspected for discal remnants. If an osteophytic component is present, the uncovertebral joint is reduced to remove the osteophytic component. An intervertebral spacer is placed to keep height of the intervertebral disc space. No additional plate fixation is used.

FOR technique:

All patients are operated in prone position with the head fixated in a 3-point head holder. After determining the correct level on lateral radiograph, a vertical 4 cm midline incision is made, and the lateral lamina/medial facet joints are exposed. A retractor is placed adequately. Under the operating microscope or loupe magnification and after a second confirmation of the correct level, a partial hemi-laminectomy and foraminotomy with partial factectomy of the involved level is performed with high-speed drills. The percentage of the facet resection is based on the extent of the foraminal pathology. In cases of pure soft discs, the proximal root is visualized adequately for removal of the compressing disc material. In cases of foraminal stenosis, bony decompression and skeletonization of the proximal root are performed carefully using a 4-mm diamond burr, small rongeurs, and dissectors.