Trial Outcomes & Findings for A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis (NCT NCT00697827)
NCT ID: NCT00697827
Last Updated: 2012-06-11
Results Overview
The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of \< 2.5 points for patient satisfaction at 24 months.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
24 months
Results posted on
2012-06-11
Participant Flow
Participant milestones
| Measure |
In-Space
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
16
|
|
Overall Study
COMPLETED
|
26
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
In-Space
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
|---|---|---|
|
Overall Study
enrolled but not treated
|
2
|
1
|
Baseline Characteristics
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
Baseline characteristics by cohort
| Measure |
In-Space
n=28 Participants
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
n=16 Participants
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age Continuous
|
63.1 years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 6.69 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
16 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of \< 2.5 points for patient satisfaction at 24 months.
Outcome measures
| Measure |
In-Space
n=26 Participants
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
n=15 Participants
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
|---|---|---|
|
Zurich Claudication Questionnaire(ZCQ)
|
17 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 24 monthsThe Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success.
Outcome measures
| Measure |
In-Space
n=26 Participants
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
n=15 Participants
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
|---|---|---|
|
Oswestry Disability Index (ODI)
|
18 participants
Interval 0.0 to 60.0
|
6 participants
|
Adverse Events
In-Space
Serious events: 19 serious events
Other events: 21 other events
Deaths: 0 deaths
X-Stop
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
In-Space
n=28 participants at risk
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
n=16 participants at risk
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/28
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture Spine - not Spinous Process
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
Infection
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Back and Lower Extremity Pain
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Surgical and medical procedures
Index Level Surgery
|
17.9%
5/28 • Number of events 6
|
25.0%
4/16 • Number of events 4
|
|
Surgical and medical procedures
Surgery - not Index Level
|
35.7%
10/28 • Number of events 18
|
25.0%
4/16 • Number of events 7
|
Other adverse events
| Measure |
In-Space
n=28 participants at risk
The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
|
X-Stop
n=16 participants at risk
The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spinous Process Fracture
|
0.00%
0/28
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Non-spine Fractures
|
3.6%
1/28 • Number of events 2
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastrointestinal
|
14.3%
4/28 • Number of events 4
|
0.00%
0/16
|
|
Renal and urinary disorders
Genitourinary
|
3.6%
1/28 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Headache
|
3.6%
1/28 • Number of events 2
|
0.00%
0/16
|
|
Infections and infestations
Non-wound related Infection
|
3.6%
1/28 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Insomnia
|
0.00%
0/28
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
10.7%
3/28 • Number of events 3
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal spasms back
|
10.7%
3/28 • Number of events 3
|
0.00%
0/16
|
|
Nervous system disorders
Neurological
|
7.1%
2/28 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Numbness non-index level related
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Other
|
14.3%
4/28 • Number of events 8
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
7/28 • Number of events 10
|
18.8%
3/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain - back and other
|
3.6%
1/28 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Pain - incision site
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Pain - lower extremities
|
25.0%
7/28 • Number of events 12
|
31.2%
5/16 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain - neck
|
10.7%
3/28 • Number of events 4
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Pain - neck and other
|
7.1%
2/28 • Number of events 4
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Pain - other
|
10.7%
3/28 • Number of events 3
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Pain - shoulder
|
0.00%
0/28
|
12.5%
2/16 • Number of events 2
|
|
Psychiatric disorders
Psychological
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Stroke
|
3.6%
1/28 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Wound issues other
|
0.00%
0/28
|
12.5%
2/16 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All unpublished information given to the investigator by Synthes Spine shall not be published or disclosed to a third party without the prior written consent of Synthes Spine. All information concerning In-Space, Synthes Spine operations, patent application drawings, manufacturing processes, basic scientific data and design information, supplied by the sponsor to the investigator and not previously published, is considered confidential and remains the sole property of Synthes Spine.
- Publication restrictions are in place
Restriction type: OTHER