Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis Clinical Trial
— FELIXOfficial title:
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
| Verified date | October 2014 |
| Source | Paradigm Spine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Netherlands: Health Counsil of Netherlands |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 386 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Sint Lucas Andreas Ziekenhuis | Amsterdam | |
| Netherlands | Reinier De Graaf Gasthuis | Delft | |
| Netherlands | Groene Hart Ziekenhuis | Gouda | |
| Netherlands | Medical Center Alkmaar | Holland | |
| Netherlands | Diaconessenhuis | Leiden | |
| Netherlands | Leiden University Medical Center | Leiden | |
| Netherlands | Rijnland ziekenhuis, | Leiderdorp | |
| Netherlands | Canisius-Wilhelmina Ziekenhuis | Nijmegen | |
| Netherlands | Vlietland Ziekenhuis | Schiedam | |
| Netherlands | Bronovo Ziekenhuis | The Hague | |
| Netherlands | HAGA ziekenhuis | The Hague | |
| Netherlands | Medical Center Haaglanden | The Hague/Leidschendam | |
| Netherlands | Isala Klinieken | Zwolle |
| Lead Sponsor | Collaborator |
|---|---|
| Paradigm Spine |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Zurich Claudication Questionnaire (ZCQ) | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. | 5 years | No |
| Secondary | EuroQOL (EQ-5D) | The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation. | 5 years | No |
| Secondary | MRDQ | The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain. | 5 years | No |
| Secondary | SF-36 | The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients. | 5 years | No |
| Secondary | McGill Pain Questionnaire | The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain. | 5 years | No |
| Secondary | VAS Leg Pain | Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group | 5 years | No |
| Secondary | Re-operations, revisions, and major complications | Assessment of revisions, removals, re-operations, and major device-related complications. | 5 years | Yes |
| Secondary | Radiographic Assessment | Radiographic Assessment of coflex and control group | 12 months | No |