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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727752
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis Procedure: Decompression Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Surgical decompression
Surgical decompression
Procedure: Decompression
Active Comparator: coflex Interlaminar Technology
Surgical decompression followed by implantation of coflex Interlaminar Technology.
Procedure: Decompression

Primary Outcome Measures :
  1. Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ]
    ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.

Secondary Outcome Measures :
  1. EuroQOL (EQ-5D) [ Time Frame: 5 years ]
    The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.

  2. MRDQ [ Time Frame: 5 years ]
    The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.

  3. SF-36 [ Time Frame: 5 years ]
    The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.

  4. McGill Pain Questionnaire [ Time Frame: 5 years ]
    The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.

  5. VAS Leg Pain [ Time Frame: 5 years ]
    Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group

  6. Re-operations, revisions, and major complications [ Time Frame: 5 years ]
    Assessment of revisions, removals, re-operations, and major device-related complications.

  7. Radiographic Assessment [ Time Frame: 12 months ]
    Radiographic Assessment of coflex and control group

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727752

Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Reinier De Graaf Gasthuis
Delft, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Medical Center Alkmaar
Holland, Netherlands
Leiden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Rijnland ziekenhuis,
Leiderdorp, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Vlietland Ziekenhuis
Schiedam, Netherlands
Medical Center Haaglanden
The Hague/Leidschendam, Netherlands
Bronovo Ziekenhuis
The Hague, Netherlands
HAGA ziekenhuis
The Hague, Netherlands
Isala Klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Paradigm Spine

Responsible Party: Paradigm Spine Identifier: NCT01727752     History of Changes
Other Study ID Numbers: NTR1307
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases