Primary objective is to demonstrate that the effectiveness of thesurgical intervention with Coflex is equivalent to surgical decompression without fusion after 1 year after surgery.Secundary objectives are to demonstrate that surgical intervention…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Symptoms and patient satisfaction will be measured with the Zurich Claudication
Questionnaire.
Secondary outcome
The cost effectiveness as measured by the EuroQol questionnaire and costs
obtained from the patient's diary.
Background summary
Intermittent neurogenic claudication is a disorder resulting from lumbar
vertebral stenosis or a narrowing of the lumbar vertebral canal.
In first instance lumbar vertebral stenosis is treated by non-invasive methods,
such as medication and physiotherapy. If symptoms continue to progress or
become more painful, surgery to widen the spinal canal can be considered
(surgical decompression).
This operation may require an admission period up to 4 days followed by an
8-week recovery period.
In recent years a safe and effective treatment has been developed as an
alternative for surgical decompression. An implant will be inserted between the
spinal crests which will lead to distraction. The spinal canal and the neural
foramina will enlarge and symptoms will decrease. This intervention may require
a shorter recovery period.
Previous studies compared the treatment with the Coflex with the non-invasive
treatment resulting in significant better results for the Coflex compared to
non-invasive treatment.
This study will compare the results obtained with surgical decompression to
results obtained with the Coflex.
Study objective
Primary objective is to demonstrate that the effectiveness of thesurgical
intervention with Coflex is equivalent to surgical decompression without fusion
after 1 year after surgery.
Secundary objectives are to demonstrate that surgical intervention with the
Coflex is more cost effective than surgical decompression and to demonstrate
that surgical intervention with the Coflex is more effective on short-term (8
weeks to 6 months).
Study design
A prospective, randomised, blinded study comparison of two treatments.
Intervention
Surgical intervention with the Coflex device.
Study burden and risks
Patient will be asked to visit the hospital pre-operatively and at 8 weeks, 6,
12, 24, and 60 months postoperatively for a follow-up visit. During this visit
a neurological examination will be performed and the patient will be requested
to complete several questionnaires.
The risks for the patient are the risks associated with surgery under general
anaesthesia. When the patient will receive surgical decompression the patient
will be subject to similar risks.
Specific risks of treatment with the Coflex are: migration or dislodgement of
the implant, no correct positioning of the implant, fracture of the spinous
process, lack of efficiviness which may lead to reoperation and removal of the
implant.
Havenstraat 30
3115 HD Schiedam
NL
Havenstraat 30
3115 HD Schiedam
NL
Listed location countries
Age
Inclusion criteria
signed informed consent - is 45 - 80 years old at time of surgery - has intermittent neurogenic claudicatio - has received at least three months of conservative care therapy - has a regular indication for surgical intervention of INC - has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI - is physically and mentally willing and able to comply with the post-operative evaluations.
Exclusion criteria
- has cauda equina syndrome
- has Paget's disease, severe osteoporosis or metastasis to the vertebrae
- has significant scoliosis
- has a BMI > 40 kg/m2
- has had any surgery of the lumbar spine
- has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4)
- has significant instability of the lumbar spine
- has severe comorbid conditions
- has a fused segment at the indicated level
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21535.058.08 |