Degenerative Lumbar Spinal StenosisPhase 3NCT00627497
DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion
A Phase 3 study testing Single-Level Posterior Decompression, DIAM Spinal Stabilization and Fusion in people with Degenerative Lumbar Spinal Stenosis, run by Medtronic Spinal and Biologics at 9 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Single-Level Posterior Decompression, DIAM Spinal Stabilization and Fusion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2008to Dec 2010
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a symptom complex consisting of back, buttock, or groin pain (excluding symptomatic coxarthrosis) with leg pain typical of intermittent neurogenic claudication, which is defined as leg(usually calf) discomfort, pain, numbness, paresthesias, weakness, or fatigue aggravated by standing or walking and is only relieved with resting in flexed lumbar spine position
- Leg pain score ≥ 8 and back pain score ≥ 6 based on the Preop Back/ Leg Pain CRF.
- Leg pain score must be ≥ back pain score
- Narrowing of the lumbar spinal canal and/or intervertebral foramen at L2-L3, L3-L4, L4-L5 as indicated by MRI, with other MRI findings typical of spinal stenosis, such as trefoil canal shape; hypertrophy, thickening, buckling, or infolding of the ligamentum flavum; hypertrophied facet joints or facet joint capsule; annular bulging; or lateral (subarticular) stenosis.
- Must sit for at least 30 min without severe pain
- Must walk at least 100 ft unassisted
Show all 11Show fewer
- 35 yrs of age, inclusive
- Preoperative Oswestry score ≥ 40
- Child-bearing potential, pt is not pregnant or nursing and agrees not to become pregnant during study period
- Treated non-operatively for a pd of at least 6 mos
- Willing and able to comply with study plan and able to understand and sign Pt ICF
Who cannot join
- Disease state which requires destabilizing decompression
- Axial back pain with no pain in leg, buttock, or groin
- Baseline strength grade of 0 (total paralysis), 1 (palpable or visible contraction), or 2 (active movement, gravity,eliminated) in any lower extremity motor group as noted on Neuro Status CRF
- Segmental kyphosis >0° at indicated level
- Cauda equina syndrome
- Compression of nerve roots that causes neurogenic bowel, bladder dysfunction
Show all 36Show fewer
- Prior surgical procedure at involved or adjacent levels
- Diagnosed with significant peripheral neuropathy
- Significant vascular disease causing vascular claudication
- Requires tx of spinal stenosis at more than 1 lumbar level
- Significant lumbar instability, defined as > 3mm translation on flexion/extension radiographs
- Has > 3mm fixed spondylolisthesis at affected level
- BMI ≥ 40
- Sustained vertebral or hip fracture within last year
- Has the following (if "Yes" to any risk below, a lumbar spine DEXA Scan is required for eligibility)
- Previous diagnosis of osteoporosis, osteopenia, or osteomalacia
- Postmenopausal Non-Black female over age of 60 who weighs ≤ 140 lbs
- Postmenopausal female who has sustained a non traumatic hip, spine or wrist fracture
- Male over age of 60 who has sustained non-traumatic hip or spine fracture
- If level of DEXA T-score is -1.0 or lower pt is excluded from study
- Lumbar scoliosis with Cobb angle of > 15°
- Documented allergy to silicone, polyethylene, titanium or latex
- Overt or active bacterial infection, local, systemic, and/or potential for bacteremia
- Alcohol and/or drug abuser
- Received tx with investigational therapy (device and/or pharmaceutical) within 30 days prior to entering study or such tx is planned during the 24 mos following enrollment in study
- Suppressed immune system or has taken steroids at any dose daily for more than 1 mon within the last yr
- Presence of active malignancy or prior history of malignancy except for basal cell carcinoma of the skin
- History of any endocrine or metabolic disorder known to affect osteogenesis
- Chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
- History of autoimmune disease
- Disease which precludes accurate clinical evaluation of safety and effectiveness of txs in this study
- Congenital or iatrogenic posterior element insufficiency
- Moderate to advance spondylosis or pts who demonstrate advanced degenerative changes. Such advanced degenerative changes are characterized by 1 or combination of the following a Bridging osteophytes; b Reduction or absence of motion; c Collapse of the intervertebral disc space of > 50% of its normal ht
- Mentally incompetent
- Waddell Signs of Inorganic Behavior score of ≥ 3
- Prisoner
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Baton Rouge, Louisiana
Study site
Chattanooga, Tennessee
Study site
Columbus, Georgia
Study site
Fremont, California
Study site
Jacksonville, Florida
Study site
Melbourne, Florida
Study site
New Orleans, Louisiana
Study site
Temple Terrace, Florida
Study site
Winston-Salem, North Carolina
About this study
Official title: A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Degenerative Lumbar Spinal Stenosis.
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.
Read the detailed description
This pivotal clinical trial is being conducted to evaluate the DIAM Spinal Stabilization System for the treatment of single-level degenerative lumbar spinal stenosis from L2 to L5. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System. And following a decompression procedure, the device will be implanted using a posterior surgical approach. Patients in the control group will receive a lumbar decompression.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- Single-Level Posterior Decompression, DIAM Spinal Stabilization, Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Level Posterior DecompressionProcedure or surgery
The single level posterior decompression is a posterior surgical procedure.
DIAM Spinal StabilizationDevice
The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
DIAM Spinal StabilizationDevice
The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
FusionDevice
Posterolateral Interbody Fusion
| Study group | Role | What they receive |
|---|---|---|
| DIAM Group1 | Experimental | Not described Receives: Device: DIAM Spinal Stabilization |
| Single-Level Posterior Decompression | Active comparator | Not described Receives: Procedure: Single-Level Posterior Decompression |
| DIAM Group2 | Experimental | Not described Receives: Device: DIAM Spinal Stabilization |
| Posterolateral Interbody Fusion | Active comparator | Not described Receives: Device: Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Overall Success
Rate of overall success is reported as the percentage of partipants who met all of the following criteria:
- Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15);
- Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated);
- No serious adverse event classified as "surgical treatment associated";
- No additional surgical procedure classified as "failure."
Measured: 24 months after operation
Secondary outcomes (12)
Oswestry Disability Index (ODI) Score
The self-administered Oswestry Disability Index (ODI) Questionnaire was used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Measured: 24 month after operation
Success Rate of Oswestry Diability Index Scores
Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score - Post-treatment Score ≥ 15.
Measured: 24 month after operation
Success Rate of Neurological Status
Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Measured: 24 month after operation
Back Pain
Numerical rating scales are used to evaluate back pain intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." A patient's total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).
Measured: 24 month after operation
Back Pain Success Rate
Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.
Measured: 24 month after operation
Leg Pain
Numerical rating scales are used to evaluate leg intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." A patient's total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).
Measured: 24 month after operation
Leg Pain Success Rate
Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.
Measured: 24 month after operation
General Health Status (SF-36)
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.
Measured: 24 month after operation
Success Rate of SF-36 Health Survey
Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 PCS and MCS for DIAM Device vs. Single-Level Posterior Decompression were defined as: (Post Score - Pre Score) / Pre Score>= 20%. The success rates of SF-36 PCS and MCS for DIAM vs. Posterolateral Interbody Fusion were defined as: Post Score - Pre Score >= 0.
Measured: 24 month after operation
Operative Time
Measured: at the time of operation
Blood Loss
Measured: At the time of operation
Hospital Stay
Measured: At the time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: slow patient recruitment
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 Degenerative Lumbar 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627497
- Sponsor's protocol ID
- P05-05 and P07-03
- Status last verified
- Apr 2012
- First submitted
- 21 Feb 2008
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Degenerative Lumbar Spinal Stenosis.
- ClinicalTrials.gov ID
- NCT00627497
- Acronym / sponsor ID
- P05-05 and P07-03
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow patient recruitment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Posted 24 Apr 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 clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.
Detailed description
This pivotal clinical trial is being conducted to evaluate the DIAM Spinal Stabilization System for the treatment of single-level degenerative lumbar spinal stenosis from L2 to L5. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System. And following a decompression procedure, the device will be implanted using a posterior surgical approach. Patients in the control group will receive a lumbar decompression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DIAM Group1 | Experimental | Device: DIAM Spinal Stabilization |
| Single-Level Posterior Decompression | Active comparator | Procedure: Single-Level Posterior Decompression |
| DIAM Group2 | Experimental | Device: DIAM Spinal Stabilization |
| Posterolateral Interbody Fusion | Active comparator | Device: Fusion |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has a symptom complex consisting of back, buttock, or groin pain (excluding symptomatic coxarthrosis) with leg pain typical of intermittent neurogenic claudication, which is defined as leg(usually calf) discomfort, pain, numbness, paresthesias, weakness, or fatigue aggravated by standing or walking and is only relieved with resting in flexed lumbar spine position
- Leg pain score ≥ 8 and back pain score ≥ 6 based on the Preop Back/ Leg Pain CRF.
- Leg pain score must be ≥ back pain score
- Narrowing of the lumbar spinal canal and/or intervertebral foramen at L2-L3, L3-L4, L4-L5 as indicated by MRI, with other MRI findings typical of spinal stenosis, such as trefoil canal shape; hypertrophy, thickening, buckling, or infolding of the ligamentum flavum; hypertrophied facet joints or facet joint capsule; annular bulging; or lateral (subarticular) stenosis.
- Must sit for at least 30 min without severe pain
Key exclusion criteria (36 listed)
- Disease state which requires destabilizing decompression
- Axial back pain with no pain in leg, buttock, or groin
- Baseline strength grade of 0 (total paralysis), 1 (palpable or visible contraction), or 2 (active movement, gravity,eliminated) in any lower extremity motor group as noted on Neuro Status CRF
- Segmental kyphosis >0° at indicated level
- Cauda equina syndrome
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 |
|---|---|---|
| Single-Level Posterior DecompressionThe single level posterior decompression is a posterior surgical procedure. | Procedure or surgery | Single-Level Posterior Decompression |
| DIAM Spinal StabilizationThe DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach. | Device | DIAM Group1 |
| DIAM Spinal StabilizationThe DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach | Device | DIAM Group2 |
| FusionPosterolateral Interbody Fusion | Device | Posterolateral Interbody Fusion |
Primary outcome
Rate of Overall Success
Time frame: 24 months after operation
Rate of overall success is reported as the percentage of partipants who met all of the following criteria: 1. Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15); 2. Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated); 3. No serious adverse event classified as "surgical treatment associated"; 4. No additional surgical procedure classified as "failure."
12 secondary outcomes
Oswestry Disability Index (ODI) Score
Time frame: 24 month after operation
Success Rate of Oswestry Diability Index Scores
Time frame: 24 month after operation
Success Rate of Neurological Status
Time frame: 24 month after operation
Back Pain
Time frame: 24 month after operation
Back Pain Success Rate
Time frame: 24 month after operation
Leg Pain
Time frame: 24 month after operation
Leg Pain Success Rate
Time frame: 24 month after operation
General Health Status (SF-36)
Time frame: 24 month after operation
Success Rate of SF-36 Health Survey
Time frame: 24 month after operation
Operative Time
Time frame: at the time of operation
Blood Loss
Time frame: At the time of operation
Hospital Stay
Time frame: At the time of discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- 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.
9 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 Single-Level Posterior Decompression, DIAM Spinal Stabilization and Fusion in people with Degenerative Lumbar Spinal Stenosis, run by Medtronic Spinal and Biologics at 9 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 11 inclusion and 36 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 24 Apr 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?
Rate of Overall Success (time frame: 24 months after operation). 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 5 Jan 2021.