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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Decompression
Sponsored by
Paradigm Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sint Lucas Andreas Ziekenhuis
  • Reinier De Graaf Gasthuis
  • Groene Hart Ziekenhuis
  • Medical Center Alkmaar
  • Diaconessenhuis
  • Leiden University Medical Center
  • Rijnland ziekenhuis,
  • Canisius-Wilhelmina Ziekenhuis
  • Vlietland Ziekenhuis
  • Medical Center Haaglanden
  • Bronovo Ziekenhuis
  • HAGA ziekenhuis
  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical decompression

coflex Interlaminar Technology

Arm Description

Surgical decompression

Surgical decompression followed by implantation of coflex Interlaminar Technology.

Outcomes

Primary Outcome Measures

Zurich Claudication Questionnaire (ZCQ)
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.

Secondary Outcome Measures

EuroQOL (EQ-5D)
The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
MRDQ
The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
SF-36
The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
McGill Pain Questionnaire
The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
VAS Leg Pain
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
Assessment of revisions, removals, re-operations, and major device-related complications.
Radiographic Assessment
Radiographic Assessment of coflex and control group

Full Information

First Posted
November 12, 2012
Last Updated
March 29, 2016
Sponsor
Paradigm Spine
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1. Study Identification

Unique Protocol Identification Number
NCT01727752
Brief Title
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
Acronym
FELIX
Official Title
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paradigm Spine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical decompression
Arm Type
Active Comparator
Arm Description
Surgical decompression
Arm Title
coflex Interlaminar Technology
Arm Type
Active Comparator
Arm Description
Surgical decompression followed by implantation of coflex Interlaminar Technology.
Intervention Type
Procedure
Intervention Name(s)
Decompression
Primary Outcome Measure Information:
Title
Zurich Claudication Questionnaire (ZCQ)
Description
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
EuroQOL (EQ-5D)
Description
The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
Time Frame
5 years
Title
MRDQ
Description
The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
Time Frame
5 years
Title
SF-36
Description
The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
Time Frame
5 years
Title
McGill Pain Questionnaire
Description
The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
Time Frame
5 years
Title
VAS Leg Pain
Description
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group
Time Frame
5 years
Title
Re-operations, revisions, and major complications
Description
Assessment of revisions, removals, re-operations, and major device-related complications.
Time Frame
5 years
Title
Radiographic Assessment
Description
Radiographic Assessment of coflex and control group
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sint Lucas Andreas Ziekenhuis
City
Amsterdam
Country
Netherlands
Facility Name
Reinier De Graaf Gasthuis
City
Delft
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Medical Center Alkmaar
City
Holland
Country
Netherlands
Facility Name
Diaconessenhuis
City
Leiden
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Rijnland ziekenhuis,
City
Leiderdorp
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
Vlietland Ziekenhuis
City
Schiedam
Country
Netherlands
Facility Name
Medical Center Haaglanden
City
The Hague/Leidschendam
Country
Netherlands
Facility Name
Bronovo Ziekenhuis
City
The Hague
Country
Netherlands
Facility Name
HAGA ziekenhuis
City
The Hague
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

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

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