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

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Device: DIAM Spinal Stabilization; Device: DIAM Spinal Stabilization; Procedure: Single-Level Posterior Decompression; Device: Fusion

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States
  • Florida
    • Jacksonville, Florida, United States
    • Melbourne, Florida, United States
    • Temple Terrace, Florida, United States
  • Georgia
    • Columbus, Georgia, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
    • New Orleans, Louisiana, United States
  • North Carolina
    • Winston-Salem, North Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DIAM Group1	Device: DIAM Spinal Stabilization; The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.; Device: DIAM Spinal Stabilization; The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
ACTIVE_COMPARATOR: Single-Level Posterior Decompression	Procedure: Single-Level Posterior Decompression; The single level posterior decompression is a posterior surgical procedure.
EXPERIMENTAL: DIAM Group2	Device: DIAM Spinal Stabilization; The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.; Device: DIAM Spinal Stabilization; The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
ACTIVE_COMPARATOR: Posterolateral Interbody Fusion	Device: Fusion; Posterolateral Interbody Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	24 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	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%.	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).	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%.	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.	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.	24 month after operation
Operative Time		at the time of operation
Blood Loss		At the time of operation
Hospital Stay		At the time of discharge

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: February 21, 2008
• First Submitted That Met QC Criteria: February 21, 2008
• First Posted (ESTIMATE): March 3, 2008

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: P05-05 and P07-03