Spinal StenosisPhase 3In-SpaceNCT00697827
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
A Phase 3 study testing Interspinous Spacer device and Interspinous Process Distraction Device in people with Spinal Stenosis, run by Synthes USA HQ, Inc. at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Interspinous Spacer device and Interspinous Process Distraction Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2008to Jun 2011
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
OrthoCarolina Spine Center
Charlotte, North Carolina, 28209
Institute for Low Back and Neck Care
Minneapolis, Minnesota, 55407
Neurosurgical Associates at Centennial Medical Center
Nashville, Tennessee, 37203
Yale Orthopedics
New Haven, Connecticut, 06519
Cornell University Hospital
New York, New York, 10021
Neurosurgical Specialists, Inc.
Norfolk, Virginia, 23510
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Texas Back Institute
Plano, Texas, 75093
The Spine Institute
Santa Monica, California, 90404
Madigan Army Medical Center
Tacoma, Washington, 98341
About this study
Official title: A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
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.
- Conditions
- Spinal Stenosis
- Being tested
- Interspinous Spacer device, Interspinous Process Distraction Device
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interspinous Spacer deviceDevice
Device: In-Space
Interspinous Process Distraction DeviceDevice
Device: X STOP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In-Space Receives: Device: Interspinous Spacer device |
| 2 | Active comparator | X STOP Receives: Device: Interspinous Process Distraction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 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 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Study terminated due to low enrollment.
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes USA HQ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697827
- Sponsor's protocol ID
- INSP01
- Acronym
- In-Space
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2008
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT00697827
- Acronym / sponsor ID
- In-Space / INSP01
- Conditions
- Spinal Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low enrollment.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Posted 5 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Interspinous Spacer deviceIn-Space |
| 2 | Active comparator | Device: Interspinous Process Distraction DeviceX STOP |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Interspinous Spacer deviceDevice: In-Space | Device | 1 |
| Interspinous Process Distraction DeviceDevice: X STOP | Device | 2 |
Primary outcome
Zurich Claudication Questionnaire(ZCQ)
Time frame: 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.
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interspinous Spacer device and Interspinous Process Distraction Device in people with Spinal Stenosis, run by Synthes USA HQ, Inc. at 10 sites in United States.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2012). 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?
Zurich Claudication Questionnaire(ZCQ) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.