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

March 29, 2016 updated by: Paradigm Spine
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

386

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Sint Lucas Andreas Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Gouda, Netherlands
        • Groene Hart ziekenhuis
      • Holland, Netherlands
        • Medical Center Alkmaar
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Leiden, Netherlands
        • Diaconessenhuis
      • Leiderdorp, Netherlands
        • Rijnland ziekenhuis,
      • Nijmegen, Netherlands
        • Canisius-Wilhelmina Ziekenhuis
      • Schiedam, Netherlands
        • Vlietland Ziekenhuis
      • The Hague, Netherlands
        • Bronovo Ziekenhuis
      • The Hague, Netherlands
        • Haga ziekenhuis
      • The Hague/Leidschendam, Netherlands
        • Medical Center Haaglanden
      • Zwolle, Netherlands
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
MRDQ
Time Frame: 5 years
The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
5 years
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.
5 years
McGill Pain Questionnaire
Time Frame: 5 years
The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
5 years
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
5 years
Re-operations, revisions, and major complications
Time Frame: 5 years
Assessment of revisions, removals, re-operations, and major device-related complications.
5 years
Radiographic Assessment
Time Frame: 12 months
Radiographic Assessment of coflex and control group
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paradigm Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTR1307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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