Degenerative Lumbar Spinal Stenosis
Conditions
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.
Interventions
PROCEDURESingle-Level Posterior Decompression
The single level posterior decompression is a posterior surgical procedure.
DEVICEDIAM Spinal Stabilization
The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
DEVICEFusion
Posterolateral Interbody Fusion
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Overall Success | 24 months after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Oswestry Diability Index Scores | 24 month after operation | Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score - Post-treatment Score ≥ 15. |
| Success Rate of Neurological Status | 24 month after operation | 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. |
| Back Pain | 24 month after operation | 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). |
| Back Pain Success Rate | 24 month after operation | Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score \> 20%. |
| Leg Pain | 24 month after operation | 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). |
| Oswestry Disability Index (ODI) Score | 24 month after operation | 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). |
| General Health Status (SF-36) | 24 month after operation | 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. |
| Success Rate of SF-36 Health Survey | 24 month after operation | 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. |
| Operative Time | at the time of operation | — |
| Blood Loss | At the time of operation | — |
| Hospital Stay | At the time of discharge | — |
| Leg Pain Success Rate | 24 month after operation | Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score \> 20%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DIAM Group1 Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach. | 14 |
| Single-Level Posterior Decompression Patients in this group received a single-level posterior lumbar decompression | 12 |
| DIAM Group2 Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach. | 4 |
| Posterolateral Interbody Fusion Patients in this group received a posterolateral interbody fusion. | 2 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Single-Level Posterior Decompression | Total | DIAM Group1 | Posterolateral Interbody Fusion | DIAM Group2 |
|---|---|---|---|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 9.7 | 54.7 years STANDARD_DEVIATION 9.8 | 56.6 years STANDARD_DEVIATION 8.3 | 54.5 years STANDARD_DEVIATION 7.8 | 47.8 years STANDARD_DEVIATION 16.1 |
| General Health Status Mental Component Summary (SF-36 MCS) | 49.7 Scores on a scale STANDARD_DEVIATION 10.5 | 50.7 Scores on a scale STANDARD_DEVIATION 9.8 | 51.7 Scores on a scale STANDARD_DEVIATION 9.2 | 59.9 Scores on a scale STANDARD_DEVIATION 4.2 | 46.0 Scores on a scale STANDARD_DEVIATION 10.7 |
| General Health Status Physical Component Summary (SF- 36 PCS) | 26.6 Scores on a scale STANDARD_DEVIATION 4.7 | 26.7 Scores on a scale STANDARD_DEVIATION 6 | 27.0 Scores on a scale STANDARD_DEVIATION 7.9 | 24.0 Scores on a scale STANDARD_DEVIATION 1.5 | 27.0 Scores on a scale STANDARD_DEVIATION 3.7 |
| Height | 66.9 in. STANDARD_DEVIATION 4.4 | 68.5 in. STANDARD_DEVIATION 4 | 70.1 in. STANDARD_DEVIATION 3.2 | 65.5 in. STANDARD_DEVIATION 0.7 | 69.3 in. STANDARD_DEVIATION 4.3 |
| Oswestry Disability Index (ODI) Score | 49.6 Scores on a scale STANDARD_DEVIATION 8.4 | 50.9 Scores on a scale STANDARD_DEVIATION 9 | 52.6 Scores on a scale STANDARD_DEVIATION 9.7 | 44.0 Scores on a scale STANDARD_DEVIATION 2.8 | 52.0 Scores on a scale STANDARD_DEVIATION 10.7 |
| Pain Status Back Pain Score (0-20) | 12.0 Scores on a scale STANDARD_DEVIATION 3.5 | 13.3 Scores on a scale STANDARD_DEVIATION 3.3 | 14.1 Scores on a scale STANDARD_DEVIATION 3.1 | 11.5 Scores on a scale STANDARD_DEVIATION 0.7 | 15.0 Scores on a scale STANDARD_DEVIATION 3.4 |
| Pain Status Leg Pain Score (0-20) | 17.1 Scores on a scale STANDARD_DEVIATION 1.7 | 17.0 Scores on a scale STANDARD_DEVIATION 2 | 17.2 Scores on a scale STANDARD_DEVIATION 1.5 | 16.0 Scores on a scale STANDARD_DEVIATION 4.2 | 16.8 Scores on a scale STANDARD_DEVIATION 3.9 |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 0 participants | 2 participants | 2 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Caucasian | 12 participants | 29 participants | 11 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized other | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 8 Participants | 14 Participants | 2 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 18 Participants | 12 Participants | 0 Participants | 2 Participants |
| Weight | 187.2 lbs STANDARD_DEVIATION 36.2 | 195.3 lbs STANDARD_DEVIATION 41.5 | 209.9 lbs STANDARD_DEVIATION 42 | 144.5 lbs STANDARD_DEVIATION 36.1 | 194.0 lbs STANDARD_DEVIATION 43.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 14 | 11 / 12 | 4 / 4 | 1 / 2 |
| serious Total, serious adverse events | 5 / 14 | 7 / 12 | 1 / 4 | 1 / 2 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DIAM Group1 | Rate of Overall Success | 53.8 percentage of patients |
| Single-Level Posterior Decompression | Rate of Overall Success | 27.3 percentage of patients |
| DIAM Group2 | Rate of Overall Success | 100.0 percentage of patients |
| Posterolateral Interbody Fusion | Rate of Overall Success | 50.0 percentage of patients |
Secondary
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).
Time frame: 24 month after operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIAM Group1 | Back Pain | Back Pain Score at baseline | 14.1 units on a scale | Standard Deviation 3.1 |
| DIAM Group1 | Back Pain | Pain Score change at 21 month from baseline | -8.9 units on a scale | Standard Deviation 6.2 |
| DIAM Group1 | Back Pain | Back Pain Score at 24 month | 5.4 units on a scale | Standard Deviation 5.7 |
| Single-Level Posterior Decompression | Back Pain | Back Pain Score at baseline | 12.0 units on a scale | Standard Deviation 3.5 |
| Single-Level Posterior Decompression | Back Pain | Pain Score change at 21 month from baseline | -5.9 units on a scale | Standard Deviation 5.2 |
| Single-Level Posterior Decompression | Back Pain | Back Pain Score at 24 month | 6.9 units on a scale | Standard Deviation 7.2 |
| DIAM Group2 | Back Pain | Back Pain Score at 24 month | 6.5 units on a scale | Standard Deviation 4.7 |
| DIAM Group2 | Back Pain | Back Pain Score at baseline | 15.0 units on a scale | Standard Deviation 3.4 |
| DIAM Group2 | Back Pain | Pain Score change at 21 month from baseline | -8.5 units on a scale | Standard Deviation 5.4 |
| Posterolateral Interbody Fusion | Back Pain | Back Pain Score at baseline | 11.5 units on a scale | Standard Deviation 0.7 |
| Posterolateral Interbody Fusion | Back Pain | Pain Score change at 21 month from baseline | -6.5 units on a scale | Standard Deviation 3.5 |
| Posterolateral Interbody Fusion | Back Pain | Back Pain Score at 24 month | 5.0 units on a scale | Standard Deviation 2.8 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DIAM Group1 | Back Pain Success Rate | 76.9 percentage of participants |
| Single-Level Posterior Decompression | Back Pain Success Rate | 75.0 percentage of participants |
| DIAM Group2 | Back Pain Success Rate | 100.0 percentage of participants |
| Posterolateral Interbody Fusion | Back Pain Success Rate | 100.0 percentage of participants |
Secondary
Blood Loss
Time frame: At the time of operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIAM Group1 | Blood Loss | 82.5 ml | Standard Deviation 68.6 |
| Single-Level Posterior Decompression | Blood Loss | 77.9 ml | Standard Deviation 108.9 |
| DIAM Group2 | Blood Loss | 57.5 ml | Standard Deviation 29.9 |
| Posterolateral Interbody Fusion | Blood Loss | 155.0 ml | Standard Deviation 63.6 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIAM Group1 | General Health Status (SF-36) | Physical Component Summary (PCS) Score at baseline | 27.0 Scores on a scale | Standard Deviation 7.9 |
| DIAM Group1 | General Health Status (SF-36) | Physical Component Summary (PCS) Score at 24 month | 44.7 Scores on a scale | Standard Deviation 12.1 |
| DIAM Group1 | General Health Status (SF-36) | PCS Score Change at 24 month from baseline | 17.2 Scores on a scale | Standard Deviation 12 |
| DIAM Group1 | General Health Status (SF-36) | Mental Component Summary (MCS) Score at baseline | 51.7 Scores on a scale | Standard Deviation 9.2 |
| DIAM Group1 | General Health Status (SF-36) | Mental Component Summary (MCS) Score at 24 month | 54.9 Scores on a scale | Standard Deviation 8.8 |
| DIAM Group1 | General Health Status (SF-36) | MCS Score Change at 24 month from baseline | 3.6 Scores on a scale | Standard Deviation 9.3 |
| Single-Level Posterior Decompression | General Health Status (SF-36) | MCS Score Change at 24 month from baseline | 2.7 Scores on a scale | Standard Deviation 6.7 |
| Single-Level Posterior Decompression | General Health Status (SF-36) | Mental Component Summary (MCS) Score at baseline | 49.7 Scores on a scale | Standard Deviation 10.5 |
| Single-Level Posterior Decompression | General Health Status (SF-36) | Physical Component Summary (PCS) Score at baseline | 26.6 Scores on a scale | Standard Deviation 4.7 |
| Single-Level Posterior Decompression | General Health Status (SF-36) | PCS Score Change at 24 month from baseline | 17.5 Scores on a scale | Standard Deviation 12.4 |
| Single-Level Posterior Decompression | General Health Status (SF-36) | Physical Component Summary (PCS) Score at 24 month | 44.4 Scores on a scale | Standard Deviation 11.8 |
| Single-Level Posterior Decompression | General Health Status (SF-36) | Mental Component Summary (MCS) Score at 24 month | 56.7 Scores on a scale | Standard Deviation 9.3 |
| DIAM Group2 | General Health Status (SF-36) | Physical Component Summary (PCS) Score at 24 month | 45.2 Scores on a scale | Standard Deviation 12.6 |
| DIAM Group2 | General Health Status (SF-36) | PCS Score Change at 24 month from baseline | 18.1 Scores on a scale | Standard Deviation 11.6 |
| DIAM Group2 | General Health Status (SF-36) | Mental Component Summary (MCS) Score at baseline | 46.0 Scores on a scale | Standard Deviation 10.7 |
| DIAM Group2 | General Health Status (SF-36) | MCS Score Change at 24 month from baseline | 9.4 Scores on a scale | Standard Deviation 9.2 |
| DIAM Group2 | General Health Status (SF-36) | Mental Component Summary (MCS) Score at 24 month | 55.4 Scores on a scale | Standard Deviation 2.8 |
| DIAM Group2 | General Health Status (SF-36) | Physical Component Summary (PCS) Score at baseline | 27.0 Scores on a scale | Standard Deviation 3.7 |
| Posterolateral Interbody Fusion | General Health Status (SF-36) | Mental Component Summary (MCS) Score at 24 month | 53.9 Scores on a scale | Standard Deviation 4.1 |
| Posterolateral Interbody Fusion | General Health Status (SF-36) | MCS Score Change at 24 month from baseline | -6.0 Scores on a scale | Standard Deviation 0.1 |
| Posterolateral Interbody Fusion | General Health Status (SF-36) | Physical Component Summary (PCS) Score at 24 month | 46.6 Scores on a scale | Standard Deviation 11.3 |
| Posterolateral Interbody Fusion | General Health Status (SF-36) | Mental Component Summary (MCS) Score at baseline | 59.9 Scores on a scale | Standard Deviation 4.2 |
| Posterolateral Interbody Fusion | General Health Status (SF-36) | Physical Component Summary (PCS) Score at baseline | 24.0 Scores on a scale | Standard Deviation 1.5 |
| Posterolateral Interbody Fusion | General Health Status (SF-36) | PCS Score Change at 24 month from baseline | 22.6 Scores on a scale | Standard Deviation 9.8 |
Secondary
Hospital Stay
Time frame: At the time of discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIAM Group1 | Hospital Stay | 1.4 days | Standard Deviation 0.9 |
| Single-Level Posterior Decompression | Hospital Stay | 1.6 days | Standard Deviation 1 |
| DIAM Group2 | Hospital Stay | 2.0 days | Standard Deviation 1.2 |
| Posterolateral Interbody Fusion | Hospital Stay | 3.5 days | Standard Deviation 0.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIAM Group1 | Leg Pain | Leg Pain at baseline | 17.2 units on a scale | Standard Deviation 1.5 |
| DIAM Group1 | Leg Pain | Pain Score change at 24 month from baseline | -11.7 units on a scale | Standard Deviation 6.5 |
| DIAM Group1 | Leg Pain | Leg pain at 24 month | 5.7 units on a scale | Standard Deviation 6.5 |
| Single-Level Posterior Decompression | Leg Pain | Leg Pain at baseline | 17.1 units on a scale | Standard Deviation 1.7 |
| Single-Level Posterior Decompression | Leg Pain | Pain Score change at 24 month from baseline | -8.8 units on a scale | Standard Deviation 9 |
| Single-Level Posterior Decompression | Leg Pain | Leg pain at 24 month | 8.5 units on a scale | Standard Deviation 9.2 |
| DIAM Group2 | Leg Pain | Leg pain at 24 month | 2.0 units on a scale | Standard Deviation 2.7 |
| DIAM Group2 | Leg Pain | Leg Pain at baseline | 16.8 units on a scale | Standard Deviation 3.9 |
| DIAM Group2 | Leg Pain | Pain Score change at 24 month from baseline | -14.8 units on a scale | Standard Deviation 6.6 |
| Posterolateral Interbody Fusion | Leg Pain | Leg Pain at baseline | 16.0 units on a scale | Standard Deviation 4.2 |
| Posterolateral Interbody Fusion | Leg Pain | Pain Score change at 24 month from baseline | -13.0 units on a scale | Standard Deviation 0 |
| Posterolateral Interbody Fusion | Leg Pain | Leg pain at 24 month | 3.0 units on a scale | Standard Deviation 4.2 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DIAM Group1 | Leg Pain Success Rate | 84.6 percentage of participant |
| Single-Level Posterior Decompression | Leg Pain Success Rate | 62.5 percentage of participant |
| DIAM Group2 | Leg Pain Success Rate | 100.0 percentage of participant |
| Posterolateral Interbody Fusion | Leg Pain Success Rate | 100.0 percentage of participant |
Secondary
Operative Time
Time frame: at the time of operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIAM Group1 | Operative Time | 1.8 hrs | Standard Deviation 0.7 |
| Single-Level Posterior Decompression | Operative Time | 1.1 hrs | Standard Deviation 0.6 |
| DIAM Group2 | Operative Time | 1.2 hrs | Standard Deviation 0.5 |
| Posterolateral Interbody Fusion | Operative Time | 2.4 hrs | Standard Deviation 0.9 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIAM Group1 | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at baseline | 52.6 Scores on a scale | Standard Deviation 9.7 |
| DIAM Group1 | Oswestry Disability Index (ODI) Score | Change of ODI Score at 24 month from baseline | -37.6 Scores on a scale | Standard Deviation 19 |
| DIAM Group1 | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at 24 month | 15.6 Scores on a scale | Standard Deviation 16.1 |
| Single-Level Posterior Decompression | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at baseline | 49.6 Scores on a scale | Standard Deviation 8.4 |
| Single-Level Posterior Decompression | Oswestry Disability Index (ODI) Score | Change of ODI Score at 24 month from baseline | -36.4 Scores on a scale | Standard Deviation 14.6 |
| Single-Level Posterior Decompression | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at 24 month | 13.3 Scores on a scale | Standard Deviation 15.6 |
| DIAM Group2 | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at 24 month | 14.1 Scores on a scale | Standard Deviation 10.9 |
| DIAM Group2 | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at baseline | 52.0 Scores on a scale | Standard Deviation 10.7 |
| DIAM Group2 | Oswestry Disability Index (ODI) Score | Change of ODI Score at 24 month from baseline | -37.9 Scores on a scale | Standard Deviation 11.4 |
| Posterolateral Interbody Fusion | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at baseline | 44.0 Scores on a scale | Standard Deviation 2.8 |
| Posterolateral Interbody Fusion | Oswestry Disability Index (ODI) Score | Change of ODI Score at 24 month from baseline | -24.0 Scores on a scale | Standard Deviation 19.8 |
| Posterolateral Interbody Fusion | Oswestry Disability Index (ODI) Score | Oswestry Disability Index (ODI) Score at 24 month | 20.0 Scores on a scale | Standard Deviation 22.6 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DIAM Group1 | Success Rate of Neurological Status | 61.5 percentage of particpants |
| Single-Level Posterior Decompression | Success Rate of Neurological Status | 37.5 percentage of particpants |
| DIAM Group2 | Success Rate of Neurological Status | 100.0 percentage of particpants |
| Posterolateral Interbody Fusion | Success Rate of Neurological Status | 100.0 percentage of particpants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DIAM Group1 | Success Rate of Oswestry Diability Index Scores | 84.6 percentage of participants |
| Single-Level Posterior Decompression | Success Rate of Oswestry Diability Index Scores | 100.0 percentage of participants |
| DIAM Group2 | Success Rate of Oswestry Diability Index Scores | 100.0 percentage of participants |
| Posterolateral Interbody Fusion | Success Rate of Oswestry Diability Index Scores | 50.0 percentage of participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DIAM Group1 | Success Rate of SF-36 Health Survey | Success Rate of PCS | 76.9 percentage of participants |
| DIAM Group1 | Success Rate of SF-36 Health Survey | Success Rate of MCS | 30.8 percentage of participants |
| Single-Level Posterior Decompression | Success Rate of SF-36 Health Survey | Success Rate of MCS | 12.5 percentage of participants |
| Single-Level Posterior Decompression | Success Rate of SF-36 Health Survey | Success Rate of PCS | 75.0 percentage of participants |
| DIAM Group2 | Success Rate of SF-36 Health Survey | Success Rate of PCS | 100.0 percentage of participants |
| DIAM Group2 | Success Rate of SF-36 Health Survey | Success Rate of MCS | 100.0 percentage of participants |
| Posterolateral Interbody Fusion | Success Rate of SF-36 Health Survey | Success Rate of PCS | 100.0 percentage of participants |
| Posterolateral Interbody Fusion | Success Rate of SF-36 Health Survey | Success Rate of MCS | 0.0 percentage of participants |