Expired Study
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Temple Terrace, Florida


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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 - 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) 1. Previous diagnosis of osteoporosis, osteopenia, or osteomalacia 2. Postmenopausal Non-Black female over age of 60 who weighs ≤ 140 lbs 3. Postmenopausal female who has sustained a non traumatic hip, spine or wrist fracture 4. 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


Study is Available At:


Original ID:

P05-05 and P07-03


NCT ID:

NCT00627497


Secondary ID:


Study Acronym:


Brief Title:

DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion


Official Title:

A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Degenerative Lumbar Spinal Stenosis.


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

35 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medtronic Spinal and Biologics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

slow patient recruitment


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:

Actual


Study Dates

Start Date:February 2008
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 24, 2012
First Received Date:February 21, 2008
First Results Date:November 29, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Hospital Stay
Time Frame:At the time of discharge
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood Loss
Time Frame:At the time of operation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Operative Time
Time Frame:at the time of operation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Success Rate of SF-36 Health Survey
Time Frame:24 month after operation
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:General Health Status (SF-36)
Time Frame:24 month after operation
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Leg Pain Success Rate
Time Frame:24 month after operation
Safety Issues:False
Description:Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.
Outcome Type:Secondary Outcome
Measure:Leg Pain
Time Frame:24 month after operation
Safety Issues:False
Description: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, patien
Outcome Type:Secondary Outcome
Measure:Back Pain Success Rate
Time Frame:24 month after operation
Safety Issues:False
Description:Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.
Outcome Type:Secondary Outcome
Measure:Back Pain
Time Frame:24 month after operation
Safety Issues:False
Description: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,
Outcome Type:Secondary Outcome
Measure:Success Rate of Neurological Status
Time Frame:24 month after operation
Safety Issues:True
Description: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
Outcome Type:Secondary Outcome
Measure:Success Rate of Oswestry Diability Index Scores
Time Frame:24 month after operation
Safety Issues:False
Description:Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score - Post-treatment Score ≥ 15.
Outcome Type:Secondary Outcome
Measure:Oswestry Disability Index (ODI) Score
Time Frame:24 month after operation
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure:Rate of Overall Success
Time Frame:24 months after operation
Safety Issues:True
Description: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-tre

Study Interventions

Intervention Type:Procedure
Name:Single-Level Posterior Decompression
Description:The single level posterior decompression is a posterior surgical procedure.
Arm Name:Single-Level Posterior Decompression
Intervention Type:Device
Name:DIAM Spinal Stabilization
Description:The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
Arm Name:DIAM Group1
Intervention Type:Device
Name:DIAM Spinal Stabilization
Description:The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
Arm Name:DIAM Group2
Intervention Type:Device
Name:Fusion
Description:Posterolateral Interbody Fusion
Arm Name:Posterolateral Interbody Fusion

Study Arms

Study Arm Type:Active Comparator
Arm Name:Posterolateral Interbody Fusion
Study Arm Type:Experimental
Arm Name:DIAM Group2
Study Arm Type:Active Comparator
Arm Name:Single-Level Posterior Decompression
Study Arm Type:Experimental
Arm Name:DIAM Group1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Medtronic Spinal and Biologics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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