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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014