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

NCT00627497 | Terminated Phase 3 Results DMC

• 1 other identifier: P05-05 and P07-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 9

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of Overall Success

  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."

  24 months after operation

Secondary Outcomes (12)

• Oswestry Disability Index (ODI) Score

  24 month after operation

• Success Rate of Oswestry Diability Index Scores

  24 month after operation

• Success Rate of Neurological Status

  24 month after operation

• Back Pain

  24 month after operation

• Back Pain Success Rate

  24 month after operation

Study Arms (4)

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

Interventions

Single-Level Posterior Decompression PROCEDURE

The single level posterior decompression is a posterior surgical procedure.

Single-Level Posterior Decompression

DIAM Spinal Stabilization DEVICE

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

DIAM Group1

Fusion DEVICE

Posterolateral Interbody Fusion

Posterolateral Interbody Fusion

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (9)

Unknown Facility

Fremont, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Melbourne, Florida, United States

Location

Unknown Facility

Temple Terrace, Florida, United States

Location

Unknown Facility

Columbus, Georgia, United States

Location

Unknown Facility

Baton Rouge, Louisiana, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Limitations and Caveats

Studies terminated before full cohort of participants were enrolled. Data and adverse events presented are through 24 months of follow-up.

Results Point of Contact

• Title: Clinical Department
• Organization: Medtrionic spinal and biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: March 3, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 5, 2021
• Results First Posted: April 24, 2012

Record last verified: 2012-04

Locations

US (9)