A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis (FELIX)
This study is ongoing, but not recruiting participants.
Sponsor:
Paradigm Spine
Information provided by (Responsible Party):
Paradigm Spine
ClinicalTrials.gov Identifier:
NCT01727752
First received: November 12, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
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Purpose
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
| Condition | Intervention |
|---|---|
|
Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis |
Procedure: Decompression |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis |
Resource links provided by NLM:
Further study details as provided by Paradigm Spine:
Primary Outcome Measures:
- Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ] [ Designated as safety issue: No ]ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Secondary Outcome Measures:
- EuroQOL (EQ-5D) [ Time Frame: 5 years ] [ Designated as safety issue: No ]The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
- MRDQ [ Time Frame: 5 years ] [ Designated as safety issue: No ]The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
- SF-36 [ Time Frame: 5 years ] [ Designated as safety issue: No ]The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
- McGill Pain Questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
- VAS Leg Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Assessment of revisions, removals, re-operations, and major device-related complications.
- Radiographic Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Radiographic Assessment of coflex and control group
| Estimated Enrollment: | 386 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Surgical decompression
Surgical decompression
|
Procedure: Decompression |
|
Active Comparator: coflex Interlaminar Technology
Surgical decompression followed by implantation of coflex Interlaminar Technology.
|
Procedure: Decompression |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727752
Locations
| 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, Netherlands | |
Sponsors and Collaborators
Paradigm Spine
More Information
No publications provided
| Responsible Party: | Paradigm Spine |
| ClinicalTrials.gov Identifier: | NCT01727752 History of Changes |
| Other Study ID Numbers: | NTR1307 |
| Study First Received: | November 12, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Netherlands: Health Counsil of Netherlands |
Additional relevant MeSH terms:
|
Constriction, Pathologic Spinal Stenosis Intermittent Claudication Pathological Conditions, Anatomical Spinal Diseases Bone Diseases |
Musculoskeletal Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013