Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
Conditions
Brief summary
A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis
Detailed description
In this investigation, it will be investigated whether the effectiveness of surgical intervention with Coflex® is equivalent to surgical decompression after 12 months in people with intermittent claudication. The main advantage of coflex® might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect remains. Therefore in addition, it will be investigated whether surgical intervention with coflex® is more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and whether surgical intervention with coflex® is more cost-effective after 12 months than surgical decompression.
Interventions
PROCEDUREDecompression
Sponsors
Paradigm Spine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* signed informed consent * is 40 to 85 years old at time of surgery * has INC, as noted by leg/buttock/groin pain with or without back pain. Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting in a chair * has received at least three months of conservative care therapy which may have included, but is not limited to, physical therapy, bracing, systemic and/or injected medications * 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, or has a caregiver who is willing and able to comply with, the post-operative evaluations.
Exclusion criteria
* has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence) * has Paget's disease, severe osteoporosis or metastasis to the vertebrae * has significant scoliosis (Cobb angle \> 25 degrees) * has a Body Mass Index (BMI) \> 40 kg/m2 * has had any surgery of the lumbar spine * has degenerative spondylolisthesis \> grade 1 (on a scale 1 to 4) at the affected level * has significant instability of the lumbar spine * has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study * has a fused segment at the indicated level. * has a herniated disk on the level of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zurich Claudication Questionnaire (ZCQ) | 5 years | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRDQ | 5 years | The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain. |
| SF-36 | 5 years | The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients. |
| McGill Pain Questionnaire | 5 years | The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain. |
| EuroQOL (EQ-5D) | 5 years | The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation. |
| Re-operations, revisions, and major complications | 5 years | Assessment of revisions, removals, re-operations, and major device-related complications. |
| Radiographic Assessment | 12 months | Radiographic Assessment of coflex and control group |
| VAS Leg Pain | 5 years | Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group |
Countries
Netherlands
Outcome results
None listed