Lumbar Spinal Stenosis
Conditions
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis, Facet Arthroplasty, Posterior Fusion, Facet Arthritis
Brief summary
The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.
Detailed description
Spinal Stenosis continues to be a major cause of back and leg pain. The condition is attributed to narrowing of the space around the nerves in the lumbar spine. This is often caused by the degenerative process in the spine and the facet joints. The current treatment calls for removal of bone around the affected nerve including the facet joints and fusing the posterior of the spine to ensure the segments remain stable. The ACADIA® Facet Replacement System (AFRS) allows for an anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet. Like the original facet joint, the replacement implant is designed to reproduce facet motion while restoring normal stability and motion. The ACADIA® Facet Replacement System (AFRS) has been designed on the principals that have allowed other total joint replacement procedures to provide significant patient benefits. These guiding principals include: * Anatomically based implant design * Reproducible surgical technique * Elimination of pain The ACADIA® Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint. This study will evaluate the outcomes of patients using the AFRS™ investigation compared to those receiving instrumented posterior fusion procedure. Patients will be required to complete study visits before the procedure and at 6 weeks, 3, 6, 12, 24 months post procedure and annually thereafter as required by FDA. Follow up visits consist of administration of questionnaires, radiographs and neurological assessment.
Interventions
DEVICENon-randomized ACADIA® Facet Replacement System
Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
DEVICERandomized ACADIA® Facet Replacement System
Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
DEVICERandomized Instrumented posterolateral fusion (PLF)
Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Sponsors
Globus Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 21-85 years of age and skeletally mature; * Have undergone 6 months of non-operative treatment prior to surgery; * Lateral, lateral recess and/or central canal stenosis; * Disc height measuring ≥ 4 mm at the operative level; * Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index; * A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate; * A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score; * A candidate for a decompression with full facetectomy at the operative level * Candidate for a posterior lumbar fusion; * Physically and mentally willing and able to comply evaluations; * Lives in the immediate area and has no plans to relocate;
Exclusion criteria
* Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer; * Previous lumbar fusion or disc replacement procedure; * Osteoporosis; * greater than Grade I spondylolisthesis or retrolisthesis; * Spondylolisthesis at levels other than at the operative level; * Scoliosis of the lumbar spine (defined as more than 11 deg Cobb angle) as indicated by plain X-ray films; * Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease; * Acute traumatic pars fracture at the operative/adjacent level vertebral body; * Spinal stenosis at more than three lumbar segments; * Acute trauma to the lumbar spine within the last 24 months; * Active infection at the operative level, or a systemic infection; * Physically / mentally compromised; * Systemic disease that would affect the patient's welfare or the research study. * Immunologically suppressed or immunocompromised; * Insulin-Dependent Diabetes Mellitus (Type I Diabetes); * Currently undergoing long-term steroid therapy; * Metabolic bone disease; * Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years; * Known allergy to cobalt chromium or titanium; * Used any investigational drug or device within the past 30 days; * Pending litigation related to back pain or injury; * Is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 24 months | Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome) |
| Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 24 months | Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome) |
| Number of Participants Who Maintained or Improved in Neurological Status. | 24 months | Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered Stable or Improved neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered Deteriorated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analog Scale (VAS) Right Leg Pain | 24 months | The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale. |
| Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline | 24 months | The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
| Mean Visual Analog Scale (VAS) Left Leg Pain | 24 months | The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale. |
| Mean Visual Analog Scale (VAS) Back Pain | 24 months | The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-randomized ACADIA® Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis | 46 |
| Randomized ACADIA® Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis | 227 |
| Randomized Instrumented PLF Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis | 117 |
| Total | 390 |
Baseline characteristics
| Characteristic | Non-randomized ACADIA® | Randomized ACADIA® | Randomized Instrumented PLF | Total |
|---|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 11.46 | 61.7 years STANDARD_DEVIATION 9.82 | 61.4 years STANDARD_DEVIATION 10.55 | 61.2 years STANDARD_DEVIATION 10.27 |
| Height | 67.3 inches STANDARD_DEVIATION 3.91 | 66.9 inches STANDARD_DEVIATION 4.41 | 67.4 inches STANDARD_DEVIATION 3.86 | 67.1 inches STANDARD_DEVIATION 4.19 |
| Race/Ethnicity, Customized Asian or Pacific Islander | 0 Participants | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 41 Participants | 206 Participants | 103 Participants | 350 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 12 Participants | 7 Participants | 22 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Female | 22 Participants | 119 Participants | 55 Participants | 196 Participants |
| Sex: Female, Male Male | 24 Participants | 108 Participants | 62 Participants | 194 Participants |
| Weight | 190.8 pounds STANDARD_DEVIATION 41.34 | 191.3 pounds STANDARD_DEVIATION 39.62 | 191.2 pounds STANDARD_DEVIATION 37.38 | 191.2 pounds STANDARD_DEVIATION 39.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 46 | 4 / 226 | 3 / 117 |
| other Total, other adverse events | 46 / 46 | 213 / 226 | 108 / 117 |
| serious Total, serious adverse events | 20 / 46 | 111 / 226 | 40 / 117 |
Outcome results
Primary
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized ACADIA® | Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 1.7 score on a scale | Standard Deviation 0.71 |
| Randomized ACADIA® | Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 1.6 score on a scale | Standard Deviation 0.62 |
| Randomized Instrumented PLF | Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 1.7 score on a scale | Standard Deviation 0.73 |
Primary
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
Time frame: 24 months
Population: One patient from the Randomized ACADIA group did not have ZCQ Symptom Severity data at 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized ACADIA® | Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 2.1 score on a scale | Standard Deviation 0.9 |
| Randomized ACADIA® | Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 2.0 score on a scale | Standard Deviation 0.8 |
| Randomized Instrumented PLF | Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 2.2 score on a scale | Standard Deviation 0.98 |
Primary
Number of Participants Who Maintained or Improved in Neurological Status.
Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered Stable or Improved neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered Deteriorated.
Time frame: 24 months
Population: Only patients with Neurological data at 24 months and treated with ACADIA or the control treatment were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-randomized ACADIA® | Number of Participants Who Maintained or Improved in Neurological Status. | 30 Participants |
| Randomized ACADIA® | Number of Participants Who Maintained or Improved in Neurological Status. | 155 Participants |
| Randomized Instrumented PLF | Number of Participants Who Maintained or Improved in Neurological Status. | 75 Participants |
Secondary
Mean Visual Analog Scale (VAS) Back Pain
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized ACADIA® | Mean Visual Analog Scale (VAS) Back Pain | 24.7 score on a scale | Standard Deviation 30.23 |
| Randomized ACADIA® | Mean Visual Analog Scale (VAS) Back Pain | 18.8 score on a scale | Standard Deviation 25.24 |
| Randomized Instrumented PLF | Mean Visual Analog Scale (VAS) Back Pain | 23.9 score on a scale | Standard Deviation 26.86 |
Secondary
Mean Visual Analog Scale (VAS) Left Leg Pain
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized ACADIA® | Mean Visual Analog Scale (VAS) Left Leg Pain | 17.5 score on a scale | Standard Deviation 29.72 |
| Randomized ACADIA® | Mean Visual Analog Scale (VAS) Left Leg Pain | 12.2 score on a scale | Standard Deviation 24.25 |
| Randomized Instrumented PLF | Mean Visual Analog Scale (VAS) Left Leg Pain | 16.9 score on a scale | Standard Deviation 26.68 |
Secondary
Mean Visual Analog Scale (VAS) Right Leg Pain
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized ACADIA® | Mean Visual Analog Scale (VAS) Right Leg Pain | 19.4 score on a scale | Standard Deviation 28.11 |
| Randomized ACADIA® | Mean Visual Analog Scale (VAS) Right Leg Pain | 13.2 score on a scale | Standard Deviation 24.97 |
| Randomized Instrumented PLF | Mean Visual Analog Scale (VAS) Right Leg Pain | 22.5 score on a scale | Standard Deviation 30.8 |
Secondary
Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline
The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: 24 months
Population: Six Non-randomized ACADIA®, 37 Randomized ACADIA® and 23 Randomized instrumented PLF did not complete the 24 month visit and thus were not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-randomized ACADIA® | Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline | 33 Participants |
| Randomized ACADIA® | Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline | 151 Participants |
| Randomized Instrumented PLF | Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline | 62 Participants |