A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

Conditions
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Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

Intervention / Treatment
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* Procedure: Decompression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical decompression<br>Surgical decompression | Procedure: Decompression<br> <br> |
| Active Comparator: coflex Interlaminar Technology<br>Surgical decompression followed by implantation of coflex Interlaminar Technology. | Procedure: Decompression<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zurich Claudication Questionnaire (ZCQ) | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQOL (EQ-5D) | The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation. | 5 years | 
| MRDQ | The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain. | 5 years | 
| SF-36 | The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients. | 5 years | 
| McGill Pain Questionnaire | The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain. | 5 years | 
| VAS Leg Pain | Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group | 5 years | 
| Re-operations, revisions, and major complications | Assessment of revisions, removals, re-operations, and major device-related complications. | 5 years | 
| Radiographic Assessment | Radiographic Assessment of coflex and control group | 12 months |