Intermittent Neurogenic Claudication (INC) as a Result of Spinal StenosisFELIXNCT01727752
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
A study testing Decompression in people with Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis, run by Paradigm Spine at 13 sites in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
- What is being tested?
- Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 13 sitesNetherlands
- Study dates
- Oct 2007to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
Sint Lucas Andreas Ziekenhuis
Amsterdam
Reinier De Graaf Gasthuis
Delft
Groene Hart Ziekenhuis
Gouda
Medical Center Alkmaar
Holland
Diaconessenhuis
Leiden
Leiden University Medical Center
Leiden
Rijnland ziekenhuis,
Leiderdorp
Canisius-Wilhelmina Ziekenhuis
Nijmegen
Vlietland Ziekenhuis
Schiedam
Bronovo Ziekenhuis
The Hague
HAGA ziekenhuis
The Hague
Medical Center Haaglanden
The Hague/Leidschendam
Isala Klinieken
Zwolle
About this study
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
Read the 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.
- Being tested
- Decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecompressionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical decompression | Active comparator | Surgical decompression Receives: Procedure: Decompression |
| coflex Interlaminar Technology | Active comparator | Surgical decompression followed by implantation of coflex Interlaminar Technology. Receives: Procedure: Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zurich Claudication Questionnaire (ZCQ)
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Measured: 5 years
Secondary outcomes (7)
EuroQOL (EQ-5D)
The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
Measured: 5 years
MRDQ
The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
Measured: 5 years
SF-36
The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
Measured: 5 years
McGill Pain Questionnaire
The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
Measured: 5 years
VAS Leg Pain
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group
Measured: 5 years
Re-operations, revisions, and major complications
Assessment of revisions, removals, re-operations, and major device-related complications.
Measured: 5 years
Radiographic Assessment
Radiographic Assessment of coflex and control group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2007
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Neurogenic Claudication (INC) as a Result of Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paradigm Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727752
- Sponsor's protocol ID
- NTR1307
- Acronym
- FELIX
- Status last verified
- Mar 2016
- First submitted
- 12 Nov 2012
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
- ClinicalTrials.gov ID
- NCT01727752
- Acronym / sponsor ID
- FELIX / NTR1307
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Paradigm SpineIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical decompression | Active comparator | Procedure: DecompressionSurgical decompression |
| coflex Interlaminar Technology | Active comparator | Procedure: DecompressionSurgical decompression followed by implantation of coflex Interlaminar Technology. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompression | Procedure or surgery | Surgical decompression, coflex Interlaminar Technology |
Primary outcome
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.
7 secondary outcomes
EuroQOL (EQ-5D)
Time frame: 5 years
MRDQ
Time frame: 5 years
SF-36
Time frame: 5 years
McGill Pain Questionnaire
Time frame: 5 years
VAS Leg Pain
Time frame: 5 years
Re-operations, revisions, and major complications
Time frame: 5 years
Radiographic Assessment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression in people with Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis, run by Paradigm Spine at 13 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zurich Claudication Questionnaire (ZCQ) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.