Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
Sponsor
Paradigm Spine (Industry)
Overall Status
Completed
CT.gov ID
NCT01316211
Collaborator
MDT Medical Device Testing GmbH (Industry), Musculoskeletal Clinical Regulatory Advisers (Other)
246
8
2
79
30.8
0.4
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
Actual Enrollment
:
246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jan 1, 2008
Actual Primary Completion Date
:
Aug 1, 2014
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: coflex™ Implantation of coflex™ device in assigned patients |
Device: Implantation of coflex™ after surgical decompression
The device will be implanted after surgical decompression in patients with spinal stenosis.
|
| Active Comparator: Surgical decompression Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. |
Procedure: Surgical decompression
Surgical decompression in patients with spinal stenosis without stabilization by an additional implant
|
Outcome Measures
Primary Outcome Measures
- Change in ODI From Baseline to 24 Months [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).
Secondary Outcome Measures
- Number of Participants With Significant Migration or Expulsion of the Implant [2 years]
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).
- Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months [Baseline, 3, 12, and 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.
- Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months [Baseline, 3, 12, and 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.
- Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months [Baseline, 3, 12, and 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.
- Assessment of Time to Symptoms Utilizing Walking Distance Test [2 years]
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
- Number of Participants With Adverse Events - Operative Site [2 years]
Number of Participants that experience adverse events related to the operative site from each group.
- The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups.. [2 years]
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.
- Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline. [Baseline, 3, 12, and 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.
- Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months [Baseline, 3, 12, and 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.
- Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months [Baseline, Day 0 (Surgery), 3, 12, and 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.
- Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months [Baseline, Day 0 (Surgery), 3, 12, and 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.
- Number of Participants Receiving Epidural Injections [2 years]
Epidural injections at up to 24 months
- Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months. [Baseline, Day 0 (Surgery), 3, 12, and 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.
- Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months. [Baseline, Day 0 (Surgery), 3, 12, and 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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.
-
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.
Exclusion Criteria
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.
-
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).
-
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oberlinklinik Potsdam Orthopädische Fachklinik | Potsdam | Brandenburg | Germany | 14482 |
| 2 | Orthopädische Universitätsklinik Frankfurt a.M. | Frankfurt a.M. | Hesse | Germany | 60528 |
| 3 | Chirurgische Universitätsklinik Rostock Neurochirurgie | Rostock | Mecklenburg-Western Pomerania | Germany | 18057 |
| 4 | Otto-von-Guericke-Universität Magdeburg Klinik für Orthopädie | Magdeburg | Saxony-Anhalt | Germany | 39120 |
| 5 | Ostseeklinik Damp Neurochirurgie | Damp | Schleswig-Holstein | Germany | 24351 |
| 6 | Klinik für Neurochirurgie Lübeck | Lübeck | Schleswig-Holstein | Germany | 23730 |
| 7 | Klinik für Wirbelsäulenchirurgie mit Skoliosezentrum Klinikum Neustadt | Neustadt | Schleswig-Holstein | Germany | 23730 |
| 8 | Klinikum Ingolstadt Neurochirurgie | Ingolstadt | Germany | 85049 |
Sponsors and Collaborators
- Paradigm Spine
- MDT Medical Device Testing GmbH
- Musculoskeletal Clinical Regulatory Advisers
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Paradigm Spine
ClinicalTrials.gov Identifier:
NCT01316211
Other Study ID Numbers:
- 06k004
First Posted:
Mar 16, 2011
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Paradigm Spine
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 120 patients in the Coflex group and 126 in the control group underwent surgery. 4 Coflex patients and 3 Control patients had to be excluded from full-analysis population, since no follow-up values were recorded and the reason of drop-out did not indicate treatment failure. |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Period Title: Overall Study | ||
| STARTED | 116 | 123 |
| COMPLETED | 105 | 111 |
| NOT COMPLETED | 11 | 12 |
Baseline Characteristics
| Arm/Group Title | Coflex™ | Surgical Decompression | Total |
|---|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant | Total of all reporting groups |
| Overall Participants | 116 | 123 | 239 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
68
(9)
|
68
(8)
|
68
(8.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
65
56%
|
61
49.6%
|
126
52.7%
|
| Male |
51
44%
|
62
50.4%
|
113
47.3%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Germany |
116
100%
|
123
100%
|
239
100%
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
84
(15)
|
84
(17)
|
84
(16.1)
|
| Height (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
170
(9)
|
170
(9)
|
170
(9.4)
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
29.0
(4.3)
|
29.1
(4.7)
|
29
(4.6)
|
Outcome Measures
| Title | Change in ODI From Baseline to 24 Months |
|---|---|
| Description | 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). |
| Time Frame | Baseline, 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [percentage points] |
-19.0
(2.1)
|
-22.5
(2.2)
|
| Title | Number of Participants With Significant Migration or Expulsion of the Implant |
|---|---|
| Description | 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). |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ |
|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. |
| Measure Participants | 105 |
| Count of Participants [Participants] |
2
1.7%
|
| Title | Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [mm] |
-23.5
(2.8)
|
-23.1
(2.7)
|
| Title | Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [mm] |
-24.3
(2.5)
|
-20.6
(2.3)
|
| Title | Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months |
|---|---|
| Description | Sensory deficits will be assessed at nerves roots from L3, L4, L5, and S1. Grading score ranges from 1=absent to 3=normal. |
| Time Frame | Baseline, 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [score on a scale] |
0.03
(0.01)
|
0.04
(0.01)
|
| Title | Assessment of Time to Symptoms Utilizing Walking Distance Test |
|---|---|
| Description | 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 |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [minutes] |
6.01
(0.65)
|
4.36
(0.64)
|
| Title | Number of Participants With Adverse Events - Operative Site |
|---|---|
| Description | Number of Participants that experience adverse events related to the operative site from each group. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 116 | 123 |
| Count of Participants [Participants] |
45
38.8%
|
54
43.9%
|
| Title | The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups.. |
|---|---|
| Description | 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. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 116 | 123 |
| Number (95% Confidence Interval) [percentage of participants] |
0.79
0.7%
|
0.76
0.6%
|
| Title | Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline. |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [percentage points] |
-15.0
(1.83)
|
-15.10
(1.75)
|
| Title | Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [percentage points] |
-3.98
(0.38)
|
-3.52
(0.37)
|
| Title | Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months |
|---|---|
| Description | Muscle strength will be assessed on right/left muscle strength at 6 groups of leg muscles. Score ranges from 0=contraction to 5=normal. |
| Time Frame | Baseline, Day 0 (Surgery), 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [score on a scale] |
0.002
(0.035)
|
-0.030
(0.034)
|
| Title | Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Day 0 (Surgery), 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [Degrees] |
10.8
(1.6)
|
9.6
(1.6)
|
| Title | Number of Participants Receiving Epidural Injections |
|---|---|
| Description | Epidural injections at up to 24 months |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 116 | 123 |
| Count of Participants [Participants] |
0
0%
|
2
1.6%
|
| Title | Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months. |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Day 0 (Surgery), 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [score on a scale] |
-0.08
(0.36)
|
-0.05
(0.29)
|
| Title | Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months. |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Day 0 (Surgery), 3, 12, and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Coflex™ | Surgical Decompression |
|---|---|---|
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
| Measure Participants | 105 | 111 |
| Mean (Standard Deviation) [score on a scale] |
-0.10
(.43)
|
-0.07
(.45)
|
Adverse Events
| Time Frame | 24 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were captured at either the operative site or non-operative site. | |||
| Arm/Group Title | Coflex™ | Surgical Decompression | ||
| Arm/Group Description | Implantation of coflex™ device in assigned patients Implantation of coflex™ after surgical decompression: The device will be implanted after surgical decompression in patients with spinal stenosis. | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant. Surgical decompression: Surgical decompression in patients with spinal stenosis without stabilization by an additional implant | ||
All Cause Mortality |
||||
| Coflex™ | Surgical Decompression | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/116 (0.9%) | 1/123 (0.8%) | ||
Serious Adverse Events |
||||
| Coflex™ | Surgical Decompression | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 89/116 (76.7%) | 96/123 (78%) | ||
| Blood and lymphatic system disorders | ||||
| HEMATOMA REQUIRING DRAINAGE | 2/116 (1.7%) | 1/123 (0.8%) | ||
| RESTENOSIS | 0/116 (0%) | 1/123 (0.8%) | ||
| Cardiac disorders | ||||
| ARRYTHMIA ABSOLUTA | 1/116 (0.9%) | 0/123 (0%) | ||
| CARDIAC ARRHYTHMIA | 1/116 (0.9%) | 0/123 (0%) | ||
| CARDIAC STENT | 1/116 (0.9%) | 0/123 (0%) | ||
| HEART ATTACK | 1/116 (0.9%) | 0/123 (0%) | ||
| MYOCARDIAL INFARCTION | 2/116 (1.7%) | 0/123 (0%) | ||
| SYNCOPE | 1/116 (0.9%) | 0/123 (0%) | ||
| TRANSIENT ISCHEMIC ATTACK | 1/116 (0.9%) | 0/123 (0%) | ||
| ARRHYTHMIA | 0/116 (0%) | 1/123 (0.8%) | ||
| PULMONARY EMBOLISM | 0/116 (0%) | 1/123 (0.8%) | ||
| LITTLE APOPLEXY | 0/116 (0%) | 1/123 (0.8%) | ||
| HYPERTENSIVE CRISIS | 0/116 (0%) | 1/123 (0.8%) | ||
| HYPERTONUS | 0/116 (0%) | 1/123 (0.8%) | ||
| 2 STENTS | 0/116 (0%) | 1/123 (0.8%) | ||
| AORTIC ANEURYSM | 0/116 (0%) | 1/123 (0.8%) | ||
| Ear and labyrinth disorders | ||||
| SUDDEN HEARING LOSS | 1/116 (0.9%) | 0/123 (0%) | ||
| Eye disorders | ||||
| CATARACT LEFT EYE | 1/116 (0.9%) | 0/123 (0%) | ||
| PUPIL INFARCTION | 1/116 (0.9%) | 0/123 (0%) | ||
| CATARACT | 0/116 (0%) | 1/123 (0.8%) | ||
| Gastrointestinal disorders | ||||
| Gastritis | 1/116 (0.9%) | 0/123 (0%) | ||
| COLITIS | 1/116 (0.9%) | 1/123 (0.8%) | ||
| STOMACH POLYP | 1/116 (0.9%) | 0/123 (0%) | ||
| GASTRIC BLEEDING | 0/116 (0%) | 1/123 (0.8%) | ||
| COLON INFECTION | 0/116 (0%) | 1/123 (0.8%) | ||
| General disorders | ||||
| GENERAL WEAKNESS | 1/116 (0.9%) | 0/123 (0%) | ||
| RECURRENT PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| Hepatobiliary disorders | ||||
| STENOSIS DUCTUS HEPATOCHOLEDOCHUS | 1/116 (0.9%) | 0/123 (0%) | ||
| Infections and infestations | ||||
| RIB FRACTURE WITH PNEUMONIA | 1/116 (0.9%) | 0/123 (0%) | ||
| INFECTION (DEEP) DEEP WOUND INFECTION | 1/116 (0.9%) | 0/123 (0%) | ||
| SUPERFICIAL WOUND INFECTION | 1/116 (0.9%) | 0/123 (0%) | ||
| WOUND PROBLEMS | 3/116 (2.6%) | 3/123 (2.4%) | ||
| INFECTION (DEEP) | 2/116 (1.7%) | 1/123 (0.8%) | ||
| WOUND PROBLEMS PROLONGED SECRETOR | 1/116 (0.9%) | 0/123 (0%) | ||
| HERPES ZOSTER | 0/116 (0%) | 1/123 (0.8%) | ||
| Injury, poisoning and procedural complications | ||||
| FALL | 1/116 (0.9%) | 0/123 (0%) | ||
| MILD HEAD INJURY | 1/116 (0.9%) | 0/123 (0%) | ||
| NASAL SEPTUM DEVIATION | 1/116 (0.9%) | 0/123 (0%) | ||
| PATIENT FELL DOWN, CONTUSION OF RIGHT FEMUR AND HIP | 1/116 (0.9%) | 0/123 (0%) | ||
| RADIUSFRACTURE LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| COMPONENT MIGRATION | 1/116 (0.9%) | 0/123 (0%) | ||
| DURAL VIOLATION | 1/116 (0.9%) | 1/123 (0.8%) | ||
| FRACTURE PROC SPINOSUS | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE, SPECIFY: FRACTURE SPINOUS PROCESS | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE, SPECIFY: SPINOUS PROCESS FRACTURE L4 | 1/116 (0.9%) | 0/123 (0%) | ||
| NERVE INJURY | 1/116 (0.9%) | 0/123 (0%) | ||
| L1 FRACTURE AFTER TRAUMA | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE THORACIC VERTEBRA NO.12 | 0/116 (0%) | 1/123 (0.8%) | ||
| HIP INJURY | 0/116 (0%) | 1/123 (0.8%) | ||
| TRAUMA FALL WITH LUMBAR FRACTURES | 0/116 (0%) | 1/123 (0.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Coxarthrosis | 1/116 (0.9%) | 0/123 (0%) | ||
| CERVICAL DISC HERNIATION | 1/116 (0.9%) | 0/123 (0%) | ||
| FACET PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| HIP ARTHROSIS LEFT | 2/116 (1.7%) | 0/123 (0%) | ||
| LEG PAIN RIGHT (GLUTEAL PAIN RIGHT SIDE) | 1/116 (0.9%) | 0/123 (0%) | ||
| LUMBAR BACK PAIN L5/S1 AND L3/L4 | 1/116 (0.9%) | 0/123 (0%) | ||
| MYELOPATHY CERVICULAR WITH SPONDYLODESIS C3/4 | 1/116 (0.9%) | 0/123 (0%) | ||
| S1 Syndrome | 1/116 (0.9%) | 0/123 (0%) | ||
| DISC HERNIATION L5/S1 LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| DISC HERNIATION SPINAL STENOSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| DEGENERATION NEIGHBORING SEGMENTS | 1/116 (0.9%) | 0/123 (0%) | ||
| INCREASE BACK PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| LUMBAR PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| SPONDYLODICITIS | 1/116 (0.9%) | 0/123 (0%) | ||
| SYNOVIAL CYSTS | 2/116 (1.7%) | 0/123 (0%) | ||
| BACK PAIN DUE TO ILIOSACRAL JOINT AFFECTION | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK LUMBAR PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK PAIN CONTINUED WITH FUSION L3-S1 | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK LEG AND BACK PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK LEG PAIN LEFT AND RIGHT, BACK PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| TRAUMA FRACTURE L2, NUCLEUS-PULPOSUS-PROLAPS L4/5 LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| ILIOSACRAL JOINT AFFECTION LEFT WITH NEED FOR DENERVATION | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| DYSPNOE BECAUSE OF ASTHMA | 0/116 (0%) | 1/123 (0.8%) | ||
| HIP PROSTHESIS LEFT, COXARTHROSIS LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| REPLACEMENT OF RIGHT HIP PROSTHESIS, DYSFUNCTION OF HIP PROSTHESIS | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE PROSTHESIS LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN OF LEFT HIP, ENDOPROSTHESIS | 0/116 (0%) | 1/123 (0.8%) | ||
| COXARTHROSIS, HIP TOTAL ENDOPROTHESIS | 0/116 (0%) | 1/123 (0.8%) | ||
| VIRUS PNEUMONIA | 0/116 (0%) | 1/123 (0.8%) | ||
| TUBERCULOSIS | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE PAIN, TOTAL ENDOPROSTHESIS LEFT PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| GONARTHROSIS (TEP LEFT KNEE) | 0/116 (0%) | 1/123 (0.8%) | ||
| TOTAL ENDOPROSTHESIS RIGHT HIP | 0/116 (0%) | 1/123 (0.8%) | ||
| GONALGIA LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| KNOWN COXARTHROSIS WITH TEP | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN AND SWELLING LEFT ANKLE | 0/116 (0%) | 1/123 (0.8%) | ||
| PROGRESSION OF GONARTHROSIS | 0/116 (0%) | 1/123 (0.8%) | ||
| GONARTHROSIS, KNEE PROSTHESIS LEFT 01. JUNE 2011 | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE ARTHROSIS RIGHT | 0/116 (0%) | 1/123 (0.8%) | ||
| HIP PROSTHESIS | 0/116 (0%) | 1/123 (0.8%) | ||
| RADIUS FRACTURE RIGHT | 0/116 (0%) | 1/123 (0.8%) | ||
| LUMBAR PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK LUMBAR PAIN ILIOSACRAL JOINT AFFECTION | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK FACET DENERVATION L2-S1 | 0/116 (0%) | 1/123 (0.8%) | ||
| DISC HERNIATION DISC HERNIATION | 0/116 (0%) | 3/123 (2.4%) | ||
| SPONDYLODESIS L4/L5 AUGUST 2015 | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK PERSISTENT BACK AND LEG PAIN L2-5 | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - LEG LEG PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK INCREASE PAIN BACK, LEGS | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK ACUTE INCREASE OF PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK CONTINUOUS DEGENERATION OF LUMBAL SPINE | 0/116 (0%) | 1/123 (0.8%) | ||
| DISC HERNIATION HERNIATED VERTEBRAL DISC | 0/116 (0%) | 1/123 (0.8%) | ||
| CEREBROSPINAL FLUID CYST | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - LEG ISCHIALGIA | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK BACK PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| BACK PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK RADICULOPATHY AND INCREASING BACK PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| INCREASING VENTROLISTHESIS L4/5 | 0/116 (0%) | 2/123 (1.6%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTHAEMATOMA WITH LUMBAGO AND ISCHIALGIA | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - LEG COMPRESSION | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK LUMBAGO ISCHIALGIA LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK DEGENERATION L4-S1 | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK PAIN, INSTABILITY | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK INCREASING LEG AND BACK PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| BACK PAIN, LEFT LEG PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| BREAST CANCER | 1/116 (0.9%) | 0/123 (0%) | ||
| MYELODYSPLASIA | 1/116 (0.9%) | 0/123 (0%) | ||
| PROSTATA CARCINOMA | 0/116 (0%) | 1/123 (0.8%) | ||
| CHRONICAL MYELOMA PROLIFERATIVE DISEASE | 0/116 (0%) | 1/123 (0.8%) | ||
| RELAPSE OF RECTUM CARCINOMA | 0/116 (0%) | 1/123 (0.8%) | ||
| PANCREAS TUMOR AND PANCREAS SURGERY | 0/116 (0%) | 1/123 (0.8%) | ||
| PEMPHIGUS, BASALIOMA | 0/116 (0%) | 1/123 (0.8%) | ||
| CANCER ESOPHAGUS | 0/116 (0%) | 1/123 (0.8%) | ||
| Nervous system disorders | ||||
| APOPLECTIC STROKE ARTERIA CEREBRI MEDIA RIGHT | 2/116 (1.7%) | 0/123 (0%) | ||
| MYASTHENIA GRAVIS | 1/116 (0.9%) | 0/123 (0%) | ||
| NEW OCCURRENCE OF ISCHIALGIA LEFT LEG WITH HYPAESTHESIA LEFT LEG | 0/116 (0%) | 1/123 (0.8%) | ||
| HYPAESTHESIA (WITH ACUTE PAIN LEFT LEG) | 0/116 (0%) | 1/123 (0.8%) | ||
| NEUROLOGIC DISORDER | 0/116 (0%) | 1/123 (0.8%) | ||
| HOSPITALIZATION DUE TO PARESIS | 0/116 (0%) | 1/123 (0.8%) | ||
| APOPLEXY | 0/116 (0%) | 2/123 (1.6%) | ||
| Psychiatric disorders | ||||
| PSYCHOTIC SYNDROME | 1/116 (0.9%) | 0/123 (0%) | ||
| ALCOHOL WITHDRAWAL DELIRIUM AURICULAR FIBRILLATION | 0/116 (0%) | 1/123 (0.8%) | ||
| Renal and urinary disorders | ||||
| NEPHROLITHIASIS LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| UROLOGIC PROBLEMS (PROSTATIC HYPERPLASIA) | 0/116 (0%) | 1/123 (0.8%) | ||
| CHOLECYSTITIS | 0/116 (0%) | 1/123 (0.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| PNEUMONIA | 1/116 (0.9%) | 0/123 (0%) | ||
| PNEUMONIA WITH RENAL FAILURE | 1/116 (0.9%) | 0/123 (0%) | ||
| Surgical and medical procedures | ||||
| Coronary Stent | 1/116 (0.9%) | 4/123 (3.3%) | ||
| FRACTURE PROXIMAL HUMERUS SURGERY (PLATE) | 1/116 (0.9%) | 0/123 (0%) | ||
| FUSION C5/C6 | 1/116 (0.9%) | 0/123 (0%) | ||
| HIP SURGERY, KNOWN COXARTHROSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| IMPLANTATION CORONARY STENT | 1/116 (0.9%) | 0/123 (0%) | ||
| IMPLANTATION OF TEP LEFT HIP | 1/116 (0.9%) | 0/123 (0%) | ||
| KNEE PAIN AND SURGERY LEFT 08 JUN 2011 | 1/116 (0.9%) | 0/123 (0%) | ||
| LENS EXCHANGE RIGHT EYE | 1/116 (0.9%) | 0/123 (0%) | ||
| PACE-MAKER-IMPLANTATION | 1/116 (0.9%) | 0/123 (0%) | ||
| RESECTION OF NOSE POLYPOSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| SECOND REVISION OF THE KNEE-TEP RIGHT SIDE | 1/116 (0.9%) | 0/123 (0%) | ||
| STENTS AND DILATATION | 1/116 (0.9%) | 0/123 (0%) | ||
| TOTAL RESECTION UTERUS | 1/116 (0.9%) | 0/123 (0%) | ||
| VASCULAR STENOSIS (VASCULAR STENT INGUINAL LEFT) | 1/116 (0.9%) | 0/123 (0%) | ||
| CATARACT (EYE SURGERY) | 1/116 (0.9%) | 0/123 (0%) | ||
| ENDOSCOPIC SURGERY STOMACH POLYP | 1/116 (0.9%) | 0/123 (0%) | ||
| CORONARY HEART DISEASE - BYPASS SURGERY | 0/116 (0%) | 1/123 (0.8%) | ||
| ARRHYTHMIA (PACEMAKER IMPLANTATION) | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN TESTICLE (ORCHIECTOMY LEFT) | 0/116 (0%) | 1/123 (0.8%) | ||
| OPERATION RIGHT SHOULDER | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE OPERATION LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| ENDOSCOPIC EXPLORATION FOR LYMPHATIC NOTCH HISTOLOGY | 0/116 (0%) | 1/123 (0.8%) | ||
| Vascular disorders | ||||
| PERIPHERAL ARTERIAL DISEASE BOTH LEGS | 1/116 (0.9%) | 0/123 (0%) | ||
| STENOSIS ARTERIA FEMORALIS / PERIPHERAL ARTERIAL VENOUS DISEASE | 1/116 (0.9%) | 0/123 (0%) | ||
| PAINFUL LEG WITH ELECTIVE ANGIOGRAPHY, FEMORAL ARTERIAL STENOSIS | 0/116 (0%) | 1/123 (0.8%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Coflex™ | Surgical Decompression | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 89/116 (76.7%) | 96/123 (78%) | ||
| Blood and lymphatic system disorders | ||||
| EDEMA LOWER LEGS | 1/116 (0.9%) | 0/123 (0%) | ||
| ANEMIA | 0/116 (0%) | 1/123 (0.8%) | ||
| HEMATOMA REQUIRING DRAINAGE | 0/116 (0%) | 1/123 (0.8%) | ||
| Cardiac disorders | ||||
| ANGINA PECTORIS | 1/116 (0.9%) | 0/123 (0%) | ||
| PERIPHERAL ARTERIAL DISEASE | 1/116 (0.9%) | 0/123 (0%) | ||
| CARDIAC INSUFFICIENCY | 1/116 (0.9%) | 0/123 (0%) | ||
| HYPERTENSION | 2/116 (1.7%) | 0/123 (0%) | ||
| ANEMIA | 1/116 (0.9%) | 0/123 (0%) | ||
| UNKNOWN SYNCOPE | 1/116 (0.9%) | 0/123 (0%) | ||
| CRISIS OF HYPERTENSION | 0/116 (0%) | 1/123 (0.8%) | ||
| HYPERTENSIVE CRISIS | 0/116 (0%) | 1/123 (0.8%) | ||
| HYPERTENSION | 0/116 (0%) | 1/123 (0.8%) | ||
| CHEST-PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| Ear and labyrinth disorders | ||||
| ACUTE HEARING LOSS | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN RIGHT EAR | 0/116 (0%) | 1/123 (0.8%) | ||
| BASALIOM LEFT EAR | 0/116 (0%) | 1/123 (0.8%) | ||
| Endocrine disorders | ||||
| DIABETES MELLITUS | 1/116 (0.9%) | 0/123 (0%) | ||
| ALLERGIC EXANTHEMA | 1/116 (0.9%) | 0/123 (0%) | ||
| BAD VIEW DUE TO DIABETES | 1/116 (0.9%) | 0/123 (0%) | ||
| ALLERGIC REACTION TO PLASTER | 0/116 (0%) | 1/123 (0.8%) | ||
| Eye disorders | ||||
| GLAUCOMA BOTH SIDES | 0/116 (0%) | 1/123 (0.8%) | ||
| HAEMANGIOMA LEFT EYE | 0/116 (0%) | 1/123 (0.8%) | ||
| Gastrointestinal disorders | ||||
| INFECTION INTESTINAL WITH CLOSTRIDIA | 1/116 (0.9%) | 0/123 (0%) | ||
| GASTROINTESTINAL INFECT | 1/116 (0.9%) | 0/123 (0%) | ||
| General disorders | ||||
| DIZZINESS | 1/116 (0.9%) | 0/123 (0%) | ||
| POOR GENERAL HEALTH STATUS | 1/116 (0.9%) | 0/123 (0%) | ||
| DIZZINESS | 0/116 (0%) | 1/123 (0.8%) | ||
| Infections and infestations | ||||
| WOUND PROBLEMS | 6/116 (5.2%) | 5/123 (4.1%) | ||
| HERPES LABIALIS | 1/116 (0.9%) | 0/123 (0%) | ||
| URINARY INFECTION | 1/116 (0.9%) | 1/123 (0.8%) | ||
| WOUND PROBLEMS BULKY SCAR | 0/116 (0%) | 1/123 (0.8%) | ||
| Injury, poisoning and procedural complications | ||||
| TRAUMA FALL | 1/116 (0.9%) | 0/123 (0%) | ||
| TRAUMA BACK PAIN AFTER FALL | 1/116 (0.9%) | 0/123 (0%) | ||
| DURAL VIOLATION | 3/116 (2.6%) | 19/123 (15.4%) | ||
| COMPONENT MIGRATION DORSAL MIGRATION OF COFLEX | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE, SPECIFY: FISSURE | 1/116 (0.9%) | 0/123 (0%) | ||
| DURAL VIOLATION L5/S1 | 1/116 (0.9%) | 0/123 (0%) | ||
| FALL WITH FOLLOWING BACK PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| MUSCLE INJURY LEFT GLUTEAL | 1/116 (0.9%) | 0/123 (0%) | ||
| FALL | 1/116 (0.9%) | 0/123 (0%) | ||
| ANKLE SPRAIN LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| CAR ACCIDENT WITH CERVICAL PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| DURAL VIOLATION SMALL LEAK OF DURA INTEROPERATIVE L3/4 | 0/116 (0%) | 1/123 (0.8%) | ||
| Investigations | ||||
| BREACKAGE OF A RIP | 1/116 (0.9%) | 0/123 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| COXALGIA LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| TROCHANTER PAIN BOTH SIDES RESP. PELVIC + HIP PAIN BOTH SIDES | 1/116 (0.9%) | 0/123 (0%) | ||
| HIP PAIN | 1/116 (0.9%) | 1/123 (0.8%) | ||
| KNEE PAIN BOTH SIDES | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN KNEE | 1/116 (0.9%) | 0/123 (0%) | ||
| GONARTHROSIS BOTH | 2/116 (1.7%) | 0/123 (0%) | ||
| PAIN RIGHT HIP | 3/116 (2.6%) | 1/123 (0.8%) | ||
| SHOULDER PAIN | 2/116 (1.7%) | 1/123 (0.8%) | ||
| GONARTHROSIS ACTIVATED | 1/116 (0.9%) | 0/123 (0%) | ||
| CORPUS VITREUM RETRACTION | 1/116 (0.9%) | 0/123 (0%) | ||
| CRAMPS IN THIGHS | 1/116 (0.9%) | 0/123 (0%) | ||
| GONARTHROSIS LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE OF LEFT HAND, OS TRIQUETRUM AVULSION FRACTURE | 1/116 (0.9%) | 0/123 (0%) | ||
| HIP PAIN AFTER TOTAL HIP REPLACEMENT 2003 | 1/116 (0.9%) | 0/123 (0%) | ||
| COXARTHROSIS LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| CARPAL TUNNEL SYNDROME RIGHT | 1/116 (0.9%) | 0/123 (0%) | ||
| CERVICAL MYELOPATHY | 1/116 (0.9%) | 0/123 (0%) | ||
| ILIO-SACRAL JOINT AFFECTION | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN BURSA TROCHANTERICA RIGHT | 1/116 (0.9%) | 0/123 (0%) | ||
| INCREASING COXARTHROSIS RIGHT | 1/116 (0.9%) | 0/123 (0%) | ||
| SCAPHOID-TRAPEZIUM-ARTHROSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN LEFT KNEE | 1/116 (0.9%) | 0/123 (0%) | ||
| KNEE PAIN AFTER FALL | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE RIGHT HAND | 1/116 (0.9%) | 0/123 (0%) | ||
| KNEE ARTHROSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| FINGER ARTHRITIS | 1/116 (0.9%) | 0/123 (0%) | ||
| KNEE PAIN LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN RIGHT KNEE | 1/116 (0.9%) | 0/123 (0%) | ||
| CRAMP PAIN AND DYSESTHESIA IN BOTH FEET | 1/116 (0.9%) | 0/123 (0%) | ||
| HIP ARTHROSIS LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| NECK PAIN | 1/116 (0.9%) | 1/123 (0.8%) | ||
| POTENTIAL HIP ARTHROSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| LEG PAIN LEFT >> RIGHT | 1/116 (0.9%) | 0/123 (0%) | ||
| MILD PAIN LEFT THIGH | 1/116 (0.9%) | 0/123 (0%) | ||
| FEELING OF WEAKNESS IN BOTH KNEES | 0/116 (0%) | 1/123 (0.8%) | ||
| HIP PAIN INCREASING | 0/116 (0%) | 1/123 (0.8%) | ||
| FACET INFILTRATION L3/4 + L5/S1 | 0/116 (0%) | 1/123 (0.8%) | ||
| ACUTE PAIN LEFT LEG | 0/116 (0%) | 1/123 (0.8%) | ||
| PAINFUL RIGHT LEG | 0/116 (0%) | 1/123 (0.8%) | ||
| OMARTHROSIS LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| CERVICAL SYNDROME WITH MIGRAINE | 0/116 (0%) | 1/123 (0.8%) | ||
| PSEUDORADIKULARSYNDROM | 0/116 (0%) | 1/123 (0.8%) | ||
| CERVICAL SYNDROME | 0/116 (0%) | 1/123 (0.8%) | ||
| HIP PAIN LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| HAGLUND HEEL PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| GONARTHROSIS | 0/116 (0%) | 2/123 (1.6%) | ||
| FOOT PAIN ARTHRITIS | 0/116 (0%) | 1/123 (0.8%) | ||
| HIP AND KNEE PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| COXARTHROSIS | 0/116 (0%) | 2/123 (1.6%) | ||
| PAIN IN NECK | 0/116 (0%) | 1/123 (0.8%) | ||
| CRAMPS IN LEGS | 0/116 (0%) | 1/123 (0.8%) | ||
| TRICEPS TENDON RUPTURE | 0/116 (0%) | 1/123 (0.8%) | ||
| COXARTHROSIS RIGHT WITH HIP PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| ORTHOSTATIC DYSREGULATION | 0/116 (0%) | 1/123 (0.8%) | ||
| L2 OSTEOPOROTIC FRACTURE | 0/116 (0%) | 1/123 (0.8%) | ||
| ARTHRITIS LEFT KNEE | 0/116 (0%) | 1/123 (0.8%) | ||
| CERVICOBRACHIAL PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN IN BOTH KNEES AFTER FALL | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE PAIN LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK LUMBAGO, FACET-SYNDROME | 0/116 (0%) | 1/123 (0.8%) | ||
| DISCUS PROTRUSION L5/6 | 0/116 (0%) | 1/123 (0.8%) | ||
| CYST OF FACET JOINT | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - LEG LEG PAIN | 0/116 (0%) | 1/123 (0.8%) | ||
| HETROTOPIC OSSIFICATION | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK ILIO SACRAL JOINT AFFECTION BOTH SIDES | 0/116 (0%) | 1/123 (0.8%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK LUMBAGO | 0/116 (0%) | 1/123 (0.8%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| LEUKAEMIA | 1/116 (0.9%) | 0/123 (0%) | ||
| BASALIOMA SKIN | 0/116 (0%) | 1/123 (0.8%) | ||
| LIVER CANCER, KNOWN CIRRHOSIS | 0/116 (0%) | 1/123 (0.8%) | ||
| Nervous system disorders | ||||
| VERTIGO | 1/116 (0.9%) | 0/123 (0%) | ||
| DISORIENTATION CEREBRAL | 1/116 (0.9%) | 0/123 (0%) | ||
| POLYNEUROPATHY | 1/116 (0.9%) | 2/123 (1.6%) | ||
| PARASTHESIA FOREFOOT BOTH SIDES | 0/116 (0%) | 1/123 (0.8%) | ||
| PARESTHESIA FOREFOOT RIGHT | 0/116 (0%) | 1/123 (0.8%) | ||
| SUSPECT OF SEIZURES | 0/116 (0%) | 1/123 (0.8%) | ||
| VERTIGO | 0/116 (0%) | 2/123 (1.6%) | ||
| CEPHALGIA WITH CERVICOBRACHIALGIA, SYNDROME | 0/116 (0%) | 1/123 (0.8%) | ||
| DIAGNOSIS OF ENCEPHALOPATHY (MULTIPLE SCLEROSIS) | 0/116 (0%) | 1/123 (0.8%) | ||
| NEVE INJURY PARAESTHESIA LEGS | 0/116 (0%) | 1/123 (0.8%) | ||
| INCREASING ISCHIALGIA | 0/116 (0%) | 1/123 (0.8%) | ||
| NERVE AFFECTION | 0/116 (0%) | 1/123 (0.8%) | ||
| Psychiatric disorders | ||||
| SYMPTOMATIC TRANSITORY PSYCHOTIC SYNDROME | 1/116 (0.9%) | 0/123 (0%) | ||
| PSYCHOSYNDROME | 1/116 (0.9%) | 0/123 (0%) | ||
| DEPRESSION INTERMITTENT | 0/116 (0%) | 1/123 (0.8%) | ||
| NERVOUS BREAK DOWN | 0/116 (0%) | 1/123 (0.8%) | ||
| PSYCHOSIS, ALCOHOL ABUSE | 0/116 (0%) | 1/123 (0.8%) | ||
| DEPRESSION | 0/116 (0%) | 1/123 (0.8%) | ||
| Renal and urinary disorders | ||||
| RENAL INSUFFICIENCY | 1/116 (0.9%) | 0/123 (0%) | ||
| BLADDER DYSFUNCTION | 1/116 (0.9%) | 0/123 (0%) | ||
| BLADDER DISTURBANCE | 1/116 (0.9%) | 0/123 (0%) | ||
| BLADDER INFECTION/URINARY TRACT INFECTION | 0/116 (0%) | 1/123 (0.8%) | ||
| Reproductive system and breast disorders | ||||
| HYSTERIC PTOSIS | 0/116 (0%) | 1/123 (0.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK BACK PAIN, POSSIBLE BECAUSE OF KNEE PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| CEREBROSPINAL FLUID LEAKAGE | 1/116 (0.9%) | 0/123 (0%) | ||
| LOCAL OSTEOPOROSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK INCREASING BACK PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| DISC HERNIATION DISC PROLAPS L4/5 | 1/116 (0.9%) | 0/123 (0%) | ||
| SACROILIAC JOINT PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BACK INCREASING LUMBAGO | 1/116 (0.9%) | 0/123 (0%) | ||
| PAIN; NEW, AND FREQUENCY, WORSENING - BOTH LEG AND BACK LUMBOISCHIALGIA LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| FRACTURE, SPECIFY: TIIP OF SPINOUS PROCESS | 1/116 (0.9%) | 0/123 (0%) | ||
| PROGRESSIVE OSTEOCHONDROSIS | 1/116 (0.9%) | 0/123 (0%) | ||
| DISCS HERNIATION CERVICAL VERTEBRAL BODY 6/7 | 1/116 (0.9%) | 0/123 (0%) | ||
| BURSITIS TROCHANTERICA LEFT | 1/116 (0.9%) | 0/123 (0%) | ||
| BURSITIS TROCHANTERICA RIGHT | 0/116 (0%) | 1/123 (0.8%) | ||
| PARALYSIS DIAPHRAGM LEFT | 0/116 (0%) | 1/123 (0.8%) | ||
| PNEUMONIA | 0/116 (0%) | 1/123 (0.8%) | ||
| BRACHIALGIA RIGHT | 0/116 (0%) | 1/123 (0.8%) | ||
| BRACHIALGIA LEFT ARM | 0/116 (0%) | 1/123 (0.8%) | ||
| KNEE PAIN RIGHT | 0/116 (0%) | 2/123 (1.6%) | ||
| DYSPNEA | 0/116 (0%) | 1/123 (0.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| SCLEROSIS OF HAEMORRHOIDS | 1/116 (0.9%) | 0/123 (0%) | ||
| Surgical and medical procedures | ||||
| BYPASS LEG DUE TO PERIPHERAL ARTERIAL DISEASE | 1/116 (0.9%) | 0/123 (0%) | ||
| MENISCUS OPERATION RIGHT - CAUSE OF KNEE PAIN | 1/116 (0.9%) | 0/123 (0%) | ||
| CERATOACANTHOMA SURGERY | 0/116 (0%) | 1/123 (0.8%) | ||
| ONYCHECTOMY DIGIT 2 RIGHT HAND | 0/116 (0%) | 1/123 (0.8%) | ||
| Vascular disorders | ||||
| ARTERIAL STENOSIS LEFT POPLITEA | 0/116 (0%) | 1/123 (0.8%) | ||
| PROGRESSIVE ARTERIAL DISSEASE | 0/116 (0%) | 1/123 (0.8%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Fran Magee, DVM |
|---|---|
| Organization | Paradigm Spine |
| Phone | 212-367-7274 |
| fran.magee@paradigmspine.com |
Responsible Party:
Paradigm Spine
ClinicalTrials.gov Identifier:
NCT01316211
Other Study ID Numbers:
- 06k004
First Posted:
Mar 16, 2011
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020