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Completed

NCT Number: NCT01727752

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

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

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Key information

Conditions

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

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Lucas Andreas Ziekenhuis, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decompression

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Paradigm Spine

Industry

Registry information

Acronym: FELIX

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Nov 16, 2012
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.