A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
- Conditions
- Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
- Interventions
- Procedure: Decompression
- Registration Number
- NCT01727752
- Lead Sponsor
- Paradigm Spine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgical decompression Decompression Surgical decompression coflex Interlaminar Technology Decompression Surgical decompression followed by implantation of coflex Interlaminar Technology.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method MRDQ 5 years The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
EuroQOL (EQ-5D) 5 years The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
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.
VAS Leg Pain 5 years Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group
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
Trial Locations
- Locations (13)
Reinier De Graaf Gasthuis
🇳🇱Delft, Netherlands
Rijnland ziekenhuis,
🇳🇱Leiderdorp, Netherlands
HAGA ziekenhuis
🇳🇱The Hague, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Canisius-Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Bronovo Ziekenhuis
🇳🇱The Hague, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Medical Center Alkmaar
🇳🇱Holland, Netherlands
Vlietland Ziekenhuis
🇳🇱Schiedam, Netherlands
Sint Lucas Andreas Ziekenhuis
🇳🇱Amsterdam, Netherlands
Diaconessenhuis
🇳🇱Leiden, Netherlands
Medical Center Haaglanden
🇳🇱The Hague/Leidschendam, Netherlands