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

NCT ID: NCT00627497

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DIAM Group1

Group Type: EXPERIMENTAL

DIAM Spinal Stabilization

Intervention Type: DEVICE

The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.

Single-Level Posterior Decompression

Group Type: ACTIVE_COMPARATOR

Single-Level Posterior Decompression

Intervention Type: PROCEDURE

The single level posterior decompression is a posterior surgical procedure.

DIAM Group2

Group Type: EXPERIMENTAL

DIAM Spinal Stabilization

Intervention Type: DEVICE

The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach

Posterolateral Interbody Fusion

Group Type: ACTIVE_COMPARATOR

Fusion

Intervention Type: DEVICE

Posterolateral Interbody Fusion

Interventions

Single-Level Posterior Decompression

The single level posterior decompression is a posterior surgical procedure.

Intervention Type: PROCEDURE

DIAM Spinal Stabilization

The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.

Intervention Type: DEVICE

DIAM Spinal Stabilization

The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach

Intervention Type: DEVICE

Fusion

Posterolateral Interbody Fusion

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fremont, California, United States

Jacksonville, Florida, United States

Melbourne, Florida, United States

Temple Terrace, Florida, United States

Columbus, Georgia, United States

Baton Rouge, Louisiana, United States

New Orleans, Louisiana, United States

Winston-Salem, North Carolina, United States

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

P05-05 and P07-03

Identifier Type: -

Identifier Source: org_study_id