|- candidate number||3238|
|- NTR Number||NTR1307|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-apr-2008|
|- Secondary IDs||P08.009 |
|- Public Title||The FELIX trial|
|- Scientific Title||A randomised controlled trial, comparing Surgical Decompression with an Interspinous Implant in patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis.|
|- hypothesis||The null hypothesis of this research is that the ZCQ outcome of PDI surgery is similar to the ZCQ outcome os surgical decompression at 1 year after surgery.|
|- Healt Condition(s) or Problem(s) studied||Lumbar stenosis, Spine|
|- Inclusion criteria||Patient will be eligible for inclusion in the investigation if he/she |
1. Signed informed consent
2. Is 45 - 80 years old at time of surgery
3. Has intermittent neurogenic claudicatio - has received at least three months of conservative care therapy
4. Has a regular indication for surgical intervention of INC
5. Has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI
6. Is physically and mentally willing and able to comply with the post-operative evaluations.
|- Exclusion criteria||Patient will be excluded from participation in the investigation if he/she|
1. Has cauda equina syndrome
2. Has Paget's disease, severe osteoporosis or metastasis to the vertebrae
3. Has significant scoliosis
4. Has a BMI > 40 kg/m2
5. Has had any surgery of the lumbar spine
6. Has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4)
7. Has significant instability of the lumbar spine
8. Has severe comorbid conditions
9. Has a fused segment at the indicated level
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2008|
|- planned closingdate||30-apr-2015|
|- Target number of participants||386|
|- Interventions||Group A: surgical decompression.|
Group B: interspinousis implant.
|- Primary outcome||The effectiveness will be measured with the ZCQ score.|
|- Secondary outcome||Cost effectiveness as measured by the EuroQol questionnaire and costs obtained from the patient's diary.|
|- Timepoints||Follow up of all patients will be performed at 8, 26, 52, 104 and 260 weeks after surgery.|
Questionnaires will be send by mail.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| SIPS-group Leiden-The Hague|
|- CONTACT for SCIENTIFIC QUERIES||Dr. W. Peul|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||24-apr-2008 - 15-feb-2015|