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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
The single level posterior decompression is a posterior surgical procedure.
The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
Unnamed facility
Fremont, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Melbourne, Florida, United States
Unnamed facility
Temple Terrace, Florida, United States
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."
Time frame: 24 months after operation
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Posterolateral Interbody Fusion
Unnamed facility
Columbus, Georgia, United States
Unnamed facility
Baton Rouge, Louisiana, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Chattanooga, Tennessee, United States
Time frame: 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%.
Time frame: 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).
Time frame: 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%.
Time frame: 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.
Time frame: 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.
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