Spinal Stenosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device (X STOP) for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.
Interventions
DEVICEInterspinous Spacer device
Device: In-Space
DEVICEInterspinous Process Distraction Device
Device: X STOP
Sponsors
Synthes USA HQ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 50 years in age * Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair. * Zurich Claudication Questionnaire Score ≥ 2.0, * Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis * Has completed at least 6 months conservative therapy
Exclusion criteria
* Axial back pain only without leg/buttock/groin pain * Has had any prior lumbar spine surgery at any level * Significant scoliosis, defined as Cobb angle \> 10° * Spondylolisthesis \> Grade 1 or isthmic spondylolisthesis at affected level * Osteoporosis * Morbid obesity, defined as BMI \> 40 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zurich Claudication Questionnaire(ZCQ) | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 24 months | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 16 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | enrolled but not treated | 2 | 1 |
Baseline characteristics
| Characteristic | X-Stop | In-Space | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 16 Participants | 23 Participants |
| Age Continuous | 64.8 years STANDARD_DEVIATION 6.69 | 63.1 years STANDARD_DEVIATION 7.88 | 64.0 years STANDARD_DEVIATION 7.23 |
| Region of Enrollment United States | 16 participants | 28 participants | 44 participants |
| Sex: Female, Male Female | 7 Participants | 18 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 28 | 13 / 16 |
| serious Total, serious adverse events | 19 / 28 | 9 / 16 |
Outcome results
Primary
Zurich Claudication Questionnaire(ZCQ)
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.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-Space | Zurich Claudication Questionnaire(ZCQ) | 17 participants |
| X-Stop | Zurich Claudication Questionnaire(ZCQ) | 7 participants |
Secondary
Oswestry Disability Index (ODI)
The 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.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-Space | Oswestry Disability Index (ODI) | 18 participants |
| X-Stop | Oswestry Disability Index (ODI) | 6 participants |