Spinal StenosisNCT01316211
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
A study testing Implantation of coflex™ after surgical decompression and Surgical decompression in people with Spinal Stenosis, run by Paradigm Spine at 8 sites in Germany.
Trial summary
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Implantation of coflex™ after surgical decompression and Surgical decompression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 8 sitesGermany
- Study dates
- Jan 2008to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, with constriction of the central spinal canal of one or two adjacent segments in the region L3 to L5 with the need for decompression.
- If necessary additional decompression in the adjacent segment(s) may be performed avoiding any instability in the affected segment.
- In addition the following may exist (but is not obligatory):
- hypertrophy of the facet joints and subarticular recessus stenosis in the relevant segment or
- stenosis of the foramen in the relevant segment
- and/or stable retrolisthesis up to grade I verified by flexion-/extension X-ray films.
Show all 14Show fewer
- Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
- VAS back pain score of at least 50 mm on a 100 mm scale (for acute back pain or a period of at least 3 month of back pain before the onset of leg pain).
- Minimum of 3 months conservative therapy without improvement of symptoms.
- Age >40 years.
- Oswestry Low Back Pain Disability Questionnaire score of at least 18/45 (40%) for German sites or 20/50 (40%) for the US sites (The question about sexual life will be excluded).
- Suitability of the patient for a posterior surgery procedure.
- Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan, fill in of CRF pages and further study procedures.
- Personally signed informed consent form before the start of any study related procedures.
Who cannot join
- Any of the following will exclude a subject from the study:
- Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
- Radiographically confirmed damage of the vertebral body in the segment of concern in the lumbar spine (e.g. osteoporotic compression fracture or because of tumors)
- Isthmic and degenerative spondylolisthesis (anterolisthesis; retrolisthesis > grade I) or spondylolysis (Pars fracture).
- Degenerative lumbar scoliosis (> 25°).
- Adipositas (obesity). Defined as a body mass index >40.
Show all 18Show fewer
- Pregnancy, or wish to get pregnant during the course of the study.
- Known allergy for titanium and titanium alloys.
- Fluoride infections - both systemic and local.
- History of severe peripheral neuropathy.
- Significant peripheral vascular disease (claudication intermittens ≥ stage 2b).
- M. Paget or osteomalacia or other metabolic bone disorders.
- Cauda equina syndrome.
- Communicating diseases, including HIV, active hepatitis
- Patients who are lawfully kept in an institution.
- Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical trial or will not comply with requirements of the study.
- Subjects who participated in a clinical observation or therapy with X-ray during the last 10 years.
- Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety and effectiveness assessment of this trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Ostseeklinik Damp Neurochirurgie
Damp, Schleswig-Holstein, 24351
Orthopädische Universitätsklinik Frankfurt a.M.
Frankfurt a.M., Hesse, 60528
Klinikum Ingolstadt Neurochirurgie
Ingolstadt, 85049
Klinik für Neurochirurgie Lübeck
Lübeck, Schleswig-Holstein, 23730
Otto-von-Guericke-Universität Magdeburg Klinik für Orthopädie
Magdeburg, Saxony-Anhalt, 39120
Klinik für Wirbelsäulenchirurgie mit Skoliosezentrum Klinikum Neustadt
Neustadt, Schleswig-Holstein, 23730
Oberlinklinik Potsdam Orthopädische Fachklinik
Potsdam, Brandenburg, 14482
Chirurgische Universitätsklinik Rostock Neurochirurgie
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Official title: Comparative Evaluation of Clinical Outcome in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex™ Interlaminar Technology
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology
Read the detailed description
The coflex® implant for interlaminar stabilization has been in clinical use for more than 10 years and is CE-certified according to the standards and approved in the United States.
This was a randomized multicenter study to collect prospective data for potential improvement in the therapy of low back pain during the treatment of spinal stenosis. The study was conducted in Germany.
- Conditions
- Spinal Stenosis
- Being tested
- Implantation of coflex™ after surgical decompression, Surgical decompression
- Keywords
- Back Pains, Pain, Back, Pains, Back, Backache, Backaches, Back Ache, Ache, Back, Aches, Back, Back Aches, Back Pain without Radiation, Vertebrogenic Pain Syndrome, Pain Syndrome, Vertebrogenic, Pain Syndromes, Vertebrogenic, Syndrome, Vertebrogenic Pain, Syndromes, Vertebrogenic Pain, Vertebrogenic Pain Syndromes, Back Pain with Radiation, Stenosis, spinal, Caudal stenosis, Spondylopathy
- Medical subject headings
- Spinal Stenosis, Back Pain, Spinal Diseases, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of coflex™ after surgical decompressionDevice
The device will be implanted after surgical decompression in patients with spinal stenosis.
Surgical decompressionProcedure or surgery
Surgical decompression in patients with spinal stenosis without stabilization by an additional implant
| Study group | Role | What they receive |
|---|---|---|
| coflex™ | Active comparator | Implantation of coflex™ device in assigned patients Receives: Device: Implantation of coflex™ after surgical decompression |
| Surgical decompression | Active comparator | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Receives: Procedure: Surgical decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ODI From Baseline to 24 Months
The ODI, also known as the Oswestry Low Back Pain Disability Questionnaire is a questionnaire providing information on back and leg pain and the affects on managing everyday life by dividing questions into 10 sections. For this study, the questions on sexual activity will not be asked. The total possible score for each section is 0-5. The scores are then converted percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
Measured: Baseline, 3, 12, and 24 months
Secondary outcomes (14)
Number of Participants With Significant Migration or Expulsion of the Implant
Assess significant migration, defined as > 5mm by x-ray images (point of reference is the tip of the U-portion implant identified on the corresponding x-ray image).
Measured: 2 years
Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100mm scale) compared to control group. 0 = no pain and 100 = worst pain imaginable.
Measured: Baseline, 3, 12, and 24 months
Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100mm scale) compared to control group. 0 = no pain and 100 = worst pain imaginable.
Measured: Baseline, 3, 12, and 24 months
Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months
Sensory deficits will be assessed at nerves roots from L3, L4, L5, and S1. Grading score ranges from 1=absent to 3=normal.
Measured: Baseline, 3, 12, and 24 months
Assessment of Time to Symptoms Utilizing Walking Distance Test
During this test, a patient has to walk on a treadmill (speed 1.8 km/h [12]) for 15 minutes (450 m) on a 0 degree ramp incline. It will be assessed time to first symptoms, time to severe symptoms and nature of symptoms (leg weakness, leg pain, back pain, or generalized fatigue, other). A time of zero will be recorded when symptoms were present at onset. The examination will be stopped after 15 minutes or at the onset of severe symptoms.
Definition of severe symptoms is: The level of discomfort that would make patients stop their activities in usual life situations.
It is assumed that patients with additional back pain will have more problems in managing the complete walking distance and therefore may stop the walking distance test before the endpoint at 15 minutes
Measured: 2 years
Number of Participants With Adverse Events - Operative Site
Number of Participants that experience adverse events related to the operative site from each group.
Measured: 2 years
The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups..
Treatment failure is defined as any secondary intervention, severe adverse event or other parameters that define the device as ineffective or not safe. The following events/outcomes were defined as treatment failures: wound revisions, patients with trauma requiring surgical intervention, disc hernia or dura repair, and/or pain management.
Measured: 2 years
Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline.
The symptom severity scale ranges from 0 to 5 where a higher score indicates a worse outcome. Percentage of the maximum reported score for the symptom severity scale was calculated at baseline and 24 months and change in percentage score is reported in the Outcome Measure data table.
Measured: Baseline, 3, 12, and 24 months
Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months
The symptom severity scale ranges from 0 to 5 where a higher score indicates a worse outcome. Percentage of the maximum reported score for the symptom severity scale was calculated at baseline and 24 months and change in percentage score is reported in the Outcome Measure data table.
Measured: Baseline, 3, 12, and 24 months
Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months
Muscle strength will be assessed on right/left muscle strength at 6 groups of leg muscles. Score ranges from 0=contraction to 5=normal.
Measured: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months
The straight leg raise or a Laségue Test is used to assess a participant's low back pain. A positive outcome is identified if a participant experiences low back pain when the straight leg is at a certain angle (0-90 degrees). A negative test suggests a likely different cause for back pain. The test is performed on both right and left legs.
Measured: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Number of Participants Receiving Epidural Injections
Epidural injections at up to 24 months
Measured: 2 years
Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months.
Trendelenburg's sign was used to assess the neurological status of a subject. The test was taken for both the left and right sides and assessed as not present/absent (no= corresponding with a value of 1) or present (yes= corresponding to a value of 2). The average of each patient's worst side was calculated. Mean values closer to 1 indicate more patients with an absent Trendelenburg's sign, and a decrease in the mean change indicates more patients improving from a present to absent Trendelenburg's sign.
Measured: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months.
Ilio sacral join affection test was used to assess the neurological status of a subject. The test was taken for both the left and right sides and assessed as not present/absent (no= corresponding with a value of 1) or present (yes= corresponding to a value of 2). The average of each patient's worst side was calculated. Mean values closer to 1 indicate more patients with an absent llio sacral joint affection and a decrease in the mean change indicates more patients improving from a present to absent sacral join affection.
Measured: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paradigm Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDT Medical Device Testing GmbH, MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316211
- Sponsor's protocol ID
- 06k004
- Status last verified
- Jun 2020
- First submitted
- 15 Mar 2011
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
PubMed 29372860
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Clinical Outcome in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex™ Interlaminar Technology
- ClinicalTrials.gov ID
- NCT01316211
- Acronym / sponsor ID
- 06k004
- Conditions
- Spinal Stenosis
- Keywords
- Back Pains, Pain, Back, Pains, Back, Backache, Backaches, Back Ache, Ache, Back, Aches, Back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Paradigm SpineIndustry (pharma, biotech, devices)
- Collaborators
- MDT Medical Device Testing GmbH, MCRA
- Study start
- Jan 2008 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology
Detailed description
The coflex® implant for interlaminar stabilization has been in clinical use for more than 10 years and is CE-certified according to the standards and approved in the United States.
This was a randomized multicenter study to collect prospective data for potential improvement in the therapy of low back pain during the treatment of spinal stenosis. The study was conducted in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coflex™ | Active comparator | Device: Implantation of coflex™ after surgical decompressionImplantation of coflex™ device in assigned patients |
| Surgical decompression | Active comparator | Procedure: Surgical decompressionSurgical decompression in patients with spinal stenosis without stabilization by an additional implant. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, with constriction of the central spinal canal of one or two adjacent segments in the region L3 to L5 with the need for decompression.
- If necessary additional decompression in the adjacent segment(s) may be performed avoiding any instability in the affected segment.
- Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
- VAS back pain score of at least 50 mm on a 100 mm scale (for acute back pain or a period of at least 3 month of back pain before the onset of leg pain).
- Minimum of 3 months conservative therapy without improvement of symptoms.
Key exclusion criteria (18 listed)
- Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
- Radiographically confirmed damage of the vertebral body in the segment of concern in the lumbar spine (e.g. osteoporotic compression fracture or because of tumors)
- Isthmic and degenerative spondylolisthesis (anterolisthesis; retrolisthesis > grade I) or spondylolysis (Pars fracture).
- Degenerative lumbar scoliosis (> 25°).
- Adipositas (obesity). Defined as a body mass index >40.
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 |
|---|---|---|
| Implantation of coflex™ after surgical decompressionThe device will be implanted after surgical decompression in patients with spinal stenosis. | Device | coflex™ |
| Surgical decompressionSurgical decompression in patients with spinal stenosis without stabilization by an additional implant | Procedure or surgery | Surgical decompression |
Primary outcome
Change in ODI From Baseline to 24 Months
Time frame: Baseline, 3, 12, and 24 months
The ODI, also known as the Oswestry Low Back Pain Disability Questionnaire is a questionnaire providing information on back and leg pain and the affects on managing everyday life by dividing questions into 10 sections. For this study, the questions on sexual activity will not be asked. The total possible score for each section is 0-5. The scores are then converted percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
14 secondary outcomes
Number of Participants With Significant Migration or Expulsion of the Implant
Time frame: 2 years
Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months
Time frame: Baseline, 3, 12, and 24 months
Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months
Time frame: Baseline, 3, 12, and 24 months
Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months
Time frame: Baseline, 3, 12, and 24 months
Assessment of Time to Symptoms Utilizing Walking Distance Test
Time frame: 2 years
Number of Participants With Adverse Events - Operative Site
Time frame: 2 years
The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups..
Time frame: 2 years
Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline.
Time frame: Baseline, 3, 12, and 24 months
Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months
Time frame: Baseline, 3, 12, and 24 months
Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months
Time frame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months
Time frame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Number of Participants Receiving Epidural Injections
Time frame: 2 years
Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months.
Time frame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months.
Time frame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29372860Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of coflex™ after surgical decompression and Surgical decompression in people with Spinal Stenosis, run by Paradigm Spine at 8 sites in Germany.
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 14 inclusion and 18 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in ODI From Baseline to 24 Months (time frame: Baseline, 3, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316211, which also lists 1 linked publication.
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 9 Jun 2020.