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The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLEXUSâ„¢ Interspinous Spacer | Experimental |
| |
| XSTOP® Interspinous Spacer | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLEXUS(TM) Interspinous Spacer | Device | Treatment of lumbar spinal stenosis with the FLEXUSâ„¢ Interspinous Spacer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score | Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows:
| 24 months |
| Number of Participants With a Successful Neurologic Status | Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows: Motor 0 Total Paralysis
Sensory 0 Absent
Reflexes 0 Absent or Trace
Straight Leg Raise 0 0°-70° (abnormal) 1 >70°-90° (normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved. | 24 months |
| Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated | Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Oswestry Disability Index (ODI) at 24 Months | The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skyridge Medical Center | Denver | Colorado | 80124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FLEXUSâ„¢ Interspinous Spacer | FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUSâ„¢ Interspinous Spacer |
| FG001 | X-STOP® Interspinous Spacer | X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer |
| FG002 | No Treatment | Not treated with FLEXUS or X-STOP |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FLEXUSâ„¢ Interspinous Spacer | FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUSâ„¢ Interspinous Spacer |
| BG001 | X-STOP® Interspinous Spacer | X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score | Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows:
| The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module. The discrepancy in the numbers is due to an additional subject having ZCQ data at 24 months in the FLEXUS arm and one less subject with ZCQ data at 24 months in the X-STOP group. No data was collected for the "No Treatment" arm. | Posted | Count of Participants | Participants | 24 months |
|
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Adverse events were reviewed and classified by a Clinical Events Committee (CEC).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FLEXUSâ„¢ Interspinous Spacer | FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUSâ„¢ Interspinous Spacer |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Globus Medical | 610-930-1800 | 1669 | jmyer@globusmedical.com |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D001416 | Back Pain |
| D010146 | Pain |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| XSTOP® Interspinous Spacer | Device | Treatment of lumbar spinal stenosis with the XSTOP® Spacer |
|
| Number of Participants With an Absence of Implant-related Complications | Absence of implant-related complications, including device dislodgement, defined as:
| 24 months |
| 24 months |
| Mean Visual Analog Scale (VAS) - Back Pain at 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. | 24 months |
| Mean Visual Analog Scale (VAS) - Right Leg Pain at 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. | 24 months |
| Mean Visual Analog Scale (VAS) - Left Leg Pain at 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. | 24 months |
| Change of Quality of Life | Change in mental or physical composite score of the short form SF36 | 24 months |
| BG002 | No Treatment | Not treated with FLEXUS or X-STOP |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight (lbs) | Mean | Standard Deviation | lbs |
|
| Height (inches) | Mean | Standard Deviation | inches |
|
| Description |
|---|
| OG000 | FLEXUSâ„¢ Interspinous Spacer | FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUSâ„¢ Interspinous Spacer |
| OG001 | X-STOP® Interspinous Spacer | X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer |
| OG002 | No Treatment | Not treated with FLEXUS or X-STOP |
|
|
| Primary | Number of Participants With a Successful Neurologic Status | Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows: Motor 0 Total Paralysis
Sensory 0 Absent
Reflexes 0 Absent or Trace
Straight Leg Raise 0 0°-70° (abnormal) 1 >70°-90° (normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved. | The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to two less subjects having neurologic status data at 24 months in the FLEXUS arm and one less subject with neurologic status data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Primary | Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated | Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated. | The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arm. No data was collected for the "No Treatment" arm. | Posted | Count of Participants | Participants | 24 months |
|
|
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| Primary | Number of Participants With an Absence of Implant-related Complications | Absence of implant-related complications, including device dislodgement, defined as:
| The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arms. No data was collected for the "No Treatment" arm. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Mean Oswestry Disability Index (ODI) at 24 Months | The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. 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. | The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm. | Posted | Mean | Standard Deviation | score | 24 months |
|
|
|
| Secondary | Mean Visual Analog Scale (VAS) - Back Pain at 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. | The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm. | Posted | Mean | Standard Deviation | millimeters | 24 months |
|
|
|
| Secondary | Mean Visual Analog Scale (VAS) - Right Leg Pain at 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. | The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm. | Posted | Mean | Standard Deviation | millimeters | 24 months |
|
|
|
| Secondary | Mean Visual Analog Scale (VAS) - Left Leg Pain at 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. | The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm. | Posted | Mean | Standard Deviation | millimeters | 24 months |
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| Secondary | Change of Quality of Life | Change in mental or physical composite score of the short form SF36 | The short form SF36 was administered to study patients; however, we do not have the proprietary scoring system. Hence the scores could not be calculated. | Posted | 24 months |
|
|
| 5 |
| 107 |
| 41 |
| 107 |
| 77 |
| 107 |
| EG001 | X-STOP® Interspinous Spacer | X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer | 3 | 106 | 28 | 106 | 72 | 106 |
| EG002 | No Treatment | Not treated with FLEXUS or X-STOP | 0 | 2 | 0 | 2 | 2 | 2 |
| Cardiovascular | Cardiac disorders |
|
| Carpal Tunnel Syndrome | General disorders |
|
| Cerebrovascular | Vascular disorders |
|
| Compressive Peripheral Neuropathy (Non-CTS) | Nervous system disorders |
|
| Death | General disorders |
|
| Gastrointestinal | Gastrointestinal disorders |
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| Infection - Superficial Wound | Infections and infestations |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Other | General disorders |
|
| Pain - Back | Musculoskeletal and connective tissue disorders |
|
| Pain - Hip | Musculoskeletal and connective tissue disorders |
|
| Pain - Lower Extremities | Musculoskeletal and connective tissue disorders |
|
| Pain - Neck and/or Upper Extremities | Musculoskeletal and connective tissue disorders |
|
| Pseudoarthrosis | General disorders |
|
| Surgery - Index Level | Surgical and medical procedures |
|
| Surgery - Non-Index Lumbar | Surgical and medical procedures |
|
| Surgery - Non-Index Lumbar | Surgical and medical procedures |
|
| Trauma | Social circumstances |
|
| Urogenital | Renal and urinary disorders |
|
| Cardiovascular | Cardiac disorders |
|
| Carpal Tunnel Syndrome (CTS) | General disorders |
|
| Dysesthesia - Lower Extremities | Nervous system disorders |
|
| Gastrointestinal | Gastrointestinal disorders |
|
| Headache | General disorders |
|
| Infection - Other | Infections and infestations |
|
| Infection - Superficial Wound | Infections and infestations |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Neurological | Nervous system disorders |
|
| Other | General disorders |
|
| Pain - Back | Musculoskeletal and connective tissue disorders |
|
| Pain - Back and Hip | Musculoskeletal and connective tissue disorders |
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| Pain - Back and Lower Extemities | Musculoskeletal and connective tissue disorders |
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| Pain - Hip | Musculoskeletal and connective tissue disorders |
|
| Pain - Lower Extremities | Musculoskeletal and connective tissue disorders |
|
| Pain - Lower Extremities with Dysesthesia | Musculoskeletal and connective tissue disorders |
|
| Pain - Neck and/or Upper Extremities | Musculoskeletal and connective tissue disorders |
|
| Pain - Other | Musculoskeletal and connective tissue disorders |
|
| Paresthesia - Lower Extremities | General disorders |
|
| Paresthesia - Upper Extremities | General disorders |
|
| Psychological | Psychiatric disorders |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders |
|
| Spinous Process Fracture | Musculoskeletal and connective tissue disorders |
|
| Surgery - Index Level | General disorders |
|
| Trauma | Social circumstances |
|
| Urogenital | Renal and urinary disorders |
|
| Weakness | General disorders |
|
| Wound Issue | Injury, poisoning and procedural complications |
|
| Pain - Back and Lower Extemities with Dysesthesia | Musculoskeletal and connective tissue disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |