The study objectives are to compare the clinical outcome(decrease of radiculopathy), complications rates and cost-effectiveness of FOR to ACDF within the group of patients with a CRS due to soft disc compression or osteophyte compression of a…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of cervical radicular pain measured by the ODOM criteria (4 point
Likert scale) and VAS arm pain.
Secondary outcome
The secondary outcomes include Work Ability (Work Ability Index, single item),
Quality of Life (Euroqol-5D), Neck Pain (VAS), Neck disability index(NDI),
Complications and Productivity related costs(iPCQ) and medical costs(IMCQ).
Background summary
The majority of scientific data on discogenic or spondylotic foraminal stenosis
are lacking comparative data. Within this era, well-validated outcome
instruments are mandatory and there is a need for comparative data to develop
evidence based treatment recommendations. At this time, there are no
evidence-based guidelines on the most appropriate surgical treatment strategy
for cervical discogenic or spondylotic stenosis of the cervical neuroforamen.
The results of this study will provide surgical treatment recommendations for
patients with discogenic or spondylotic cervical foraminal stenosis and
contribute to the understanding of its short- and long-term clinical
postoperative course.
Study objective
The study objectives are to compare the clinical outcome(decrease of
radiculopathy), complications rates and cost-effectiveness of FOR to ACDF
within the group of patients with a CRS due to soft disc compression or
osteophyte compression of a cervical root. Work absenteeism of this specific
study group will also be studied.
Hypothesis:
H0: The null hypothesis is that the percentage for those on the ACDF treatment
is better than the percentage for those on the
FOR treatment by an amount of 10%.
H1: Reject the null hypothesis. FOR is no worse than ACDF by a delta of 10%.
In this multicenter non inferiority trial we want to reject the H0 and
accept H1.
Patients with a monosegmental cervical radiculopathy due to a lateral/foraminal
stenosis (discogenic or osteophytic
component) operated with the FOR technique will have no worse outome on the
primary endpoint(decrease of radiculopathy),
lower surgical and hospital costs, lower morbidity and lower work absenteeism
in respect to the patients operated with the
ACDF technique.
The study objectives are:
1.compare the clinical outcome(decrease of radiculopathy) of FOR to ACDF within
the group of patients with a CRS due to soft
disc compression or osteophyte compression of a cervical root.
2.compare complication rates of both FOR to ACDF,
3.compare cost-effectiveness of FOR to ACDF,
4.Investigate work absenteeism.
Study design
This study is a nationwide, prospective, multicenter, researcher blinded,
randomized controlled trial with a follow up period of 24 months.
Intervention
ACDF technique:
Microsurgical discectomy was performed through a ventral approach described by
Smith and Robinson (1958). Procedure can be executed with microscope or loup
magnification. Exploration of the intervertebral disc and removal of bony spurs
with a high-speed drill. Subsequently 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 loup magnification and after a second confirmation
of the correct level, a partial hemilaminectomy and foraminotomy with partial
facetectomy of the involved level is performed with high-speed drills. The
percent of the facet resection was 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 were
performed carefully using a 4-mm diamond burr, small rongeurs, and dissectors.
Study burden and risks
Patients are treated within the concept of *care as usual*. Both operative
techniques are part of the neurosurgeons basic skills and training. Both
operative techniques are index techniques to operate on cervical discal
herniations. Differences between risks and clinical outcome between both
procedures are unknown and are objective of this study. The burden for patients
participating in this trial is low (see table *Visit plan*). Patients are asked
to fill out questionnaires after 6, 24, 52, 78 and 104 weeks. Time to fill out
the questionnaire is approximately 30 minutes per follow up moment. There are
no benefits compared to care as usual.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54380.042.15 |
| OMON | NL-OMON24269 |