Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
Conditions
Keywords
Single or double level instrumented fusion, Degenerative lumbar spine, PLIF, TLIF, MAST procedure
Brief summary
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a real-world patient population.
Detailed description
Instrumented lumbar fusion is usually done through an open procedure which involves an excessive intraoperative dissection and retraction of the paraspinal musculature leading, in a short term basis, to a prolonged recovery time from the surgery. This open approach is frequently associated with significant blood loss and need of transfusion, produces the majority of the perioperative pain, increases hospital stay and the chances of infection and delays the return to normal activities and to work. In a long term basis, the open procedure leads to denervation, atrophy and loss of the muscles independent function, resulting in an increased risk of fusion disease, a term that has been coined to describe its occurrence. The minimally invasive spinal surgery was developed as a potential solution to the above-mentioned problems by reducing the amount of iatrogenic soft tissue injury while reaching the same traditional goals of the open procedures. Besides minimizing the long-term effects of exposure-related muscle injury, minimally invasive lumbar fusion techniques hold the promise of immediate short-term advantages. Patients undergoing minimally invasive procedures are reported to recover earlier from the surgery. Shorter time to first ambulation, less pain medication consumption, less blood loss, less required transfusion, shorter hospital stay and earlier return to work are generally associated with the minimally invasive procedure as compared to the standard open surgeries. The minimally invasive access requires a surgical corridor targeted on the disease which is accomplished by using a series of tubular muscle dilators allowing a clear intraoperative visualization to perform these procedures together with the parallel use of image guided percutaneous insertion of pedicle screws and instrumentation. The purpose of this study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF or TLIF techniques for the treatment of the degenerative lumbar spine in a real-world patient population.
Interventions
DEVICEMAST™ procedure
Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
Sponsors
Medtronic Spinal and Biologics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is \>18 years of age (or minimum age as required by local regulations). * Patient has indication for a single or double level instrumented lumbar fusion for the treatment of the degenerative lumbar spine. * Patient agrees to participate in the study and is able to sign the Data Release Form/Informed Consent. * The procedure planned for the patient complies with the labeling of the Devices that may be used in the surgical procedure as described in the section B.2 Device Information. * Patient is planned to be submitted to the fusion procedure using PLIF or TLIF techniques and to receive a CD HORIZON® Spinal System via a MAST™ approach. * The patient is willing and is able to cooperate with study procedures and required follow-up visits.
Exclusion criteria
* Patient that has already undergone an open lumbar spine surgery other than microdiscectomy. * Indications for the procedure other than degenerative spine disease like Osteoporotic vertebral fractures, Spine trauma fractures and Spine tumor. In order to reduce as much as possible bias in this observational study, the study centers should propose the study to all consecutive individuals who meet these in and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Surgery to First Ambulation. | From date of Surgery to date of First ambulation, assessed up to hospital discharge. | The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital. |
| Time to Surgery Recovery Day. | From date of surgery until date of surgery recovery day assessed up to hospital discharge. | The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline. | Baseline, 12 months | Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS). The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain. |
| Leg Pain Intensity VAS Score as Compared to Baseline | Baseline, 12 months | Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS). The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain. |
| EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline. | Baseline, 12 months | EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent's self-rated health on a vertical 20 cm VAS where the endpoints are labelled 'Best imaginable health state' at the top and 'Worst imaginable health state' at the bottom, having numeric values of 100 and 0 respectively. |
| Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care. | 12 months | Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care. |
| Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline. | Baseline, 12 months | Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit. |
| Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates). | From baseline until 12 months | Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates). |
| Proportion of Patients Needing Intervention at Adjacent Level(s). | From Baseline until 12 months | Proportion of the patients needing intervention at adjacent level(s). |
| ODI Difference 12 Months After the Surgery as Compared to Baseline. | Baseline, 12 months | Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'. |
| Number of Patients That Returned to Work 12months After the Surgery. | 12 months after the surgery | Document number of participants that returned to work 12 months after surgery. |
| Number of Patients Who Utilized Rehabilitation Programs | From 6-12 months after the day of surgery | The number of patients who utilized rehabilitation programs was documented (when required). |
| Document Adverse Events Occurrence Throughout the Study. | From Baseline until 12 months | Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing. |
Countries
Austria, Belgium, Canada, Czechia, Germany, Greece, Israel, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom
Participant flow
Pre-assignment details
In total 255 patients were enrolled. Three patients were not submitted to a minimally invasive MAST fusion procedure and therefore excluded from further analysis. Number of participants started in the participant flow is 252.
Participants by arm
| Arm | Count |
|---|---|
| MAST™ Procedure Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure. | 252 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Explant of the device | 4 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | MAST™ Procedure |
|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment Austria | 25 Participants |
| Region of Enrollment Belgium | 15 Participants |
| Region of Enrollment Canada | 14 Participants |
| Region of Enrollment Czechia | 40 Participants |
| Region of Enrollment Germany | 81 Participants |
| Region of Enrollment Greece | 1 Participants |
| Region of Enrollment Israel | 8 Participants |
| Region of Enrollment Italy | 16 Participants |
| Region of Enrollment Netherlands | 16 Participants |
| Region of Enrollment Poland | 4 Participants |
| Region of Enrollment Portugal | 10 Participants |
| Region of Enrollment Slovakia | 7 Participants |
| Region of Enrollment Spain | 4 Participants |
| Region of Enrollment United Kingdom | 11 Participants |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 66 / 252 |
| serious Total, serious adverse events | 20 / 252 |
Outcome results
Primary
Time From Surgery to First Ambulation.
The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital.
Time frame: From date of Surgery to date of First ambulation, assessed up to hospital discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MAST™ Procedure | Time From Surgery to First Ambulation. | 1.3 Days from surgery to first ambulation | Standard Deviation 0.5 |
95% CI: [1.2, 1.3]
Primary
Time to Surgery Recovery Day.
The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors.
Time frame: From date of surgery until date of surgery recovery day assessed up to hospital discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MAST™ Procedure | Time to Surgery Recovery Day. | 3.2 Days | Standard Deviation 2 |
95% CI: [2.9, 3.4]
Secondary
Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.
Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS). The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain.
Time frame: Baseline, 12 months
Population: The number of analyzed at 12 months only included subjects who had available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST™ Procedure | Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline. | Pre-operative (N=252) | 6.2 Units on a scale | Standard Deviation 2.3 |
| MAST™ Procedure | Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline. | 12 Months (N=226) | 2.9 Units on a scale | Standard Deviation 2.5 |
p-value: <0.000195% CI: [-3.6, -2.9]t-test, 2 sided
Secondary
Document Adverse Events Occurrence Throughout the Study.
Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.
Time frame: From Baseline until 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAST™ Procedure | Document Adverse Events Occurrence Throughout the Study. | 125 Number of reported adverse events |
Secondary
Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.
Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.
Time frame: Baseline, 12 months
Population: The number of analyzed at 12 months only included subjects who had available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MAST™ Procedure | Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline. | Participants taking medication at baseline N=252 | 185 Participants |
| MAST™ Procedure | Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline. | Participants taking medication at 12 months N=233 | 107 Participants |
Secondary
EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.
EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent's self-rated health on a vertical 20 cm VAS where the endpoints are labelled 'Best imaginable health state' at the top and 'Worst imaginable health state' at the bottom, having numeric values of 100 and 0 respectively.
Time frame: Baseline, 12 months
Population: The number of analyzed at 12 months only included subjects who had available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST™ Procedure | EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline. | Baseline (N=204) | 0.34 Units on a scale / Index | Standard Deviation 0.32 |
| MAST™ Procedure | EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline. | 12 Months (N=182) | 0.71 Units on a scale / Index | Standard Deviation 0.28 |
p-value: <0.000195% CI: [0.3, 0.41]t-test, 2 sided
Secondary
Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.
Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.
Time frame: 12 months
Population: One hundred and thirty one-level patients (=130 LEVELS) and 24 two-level patients (=48 LEVELS) were assessed for fusion at 12 months per CIP defined criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MAST™ Procedure | Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care. | One level fusion (levels n=130) | 118 Fused levels |
| MAST™ Procedure | Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care. | Two level fusion (levels n=48) | 43 Fused levels |
Secondary
Leg Pain Intensity VAS Score as Compared to Baseline
Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS). The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain.
Time frame: Baseline, 12 months
Population: The number of analyzed at 12 months only included subjects who had available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST™ Procedure | Leg Pain Intensity VAS Score as Compared to Baseline | Baseline (N=252) | 5.9 Units on a scale | Standard Deviation 2.8 |
| MAST™ Procedure | Leg Pain Intensity VAS Score as Compared to Baseline | 12 months (N=226) | 2.2 Units on a scale | Standard Deviation 2.6 |
p-value: <0.000195% CI: [-4.2, -3.3]t-test, 2 sided
Secondary
Number of Patients That Returned to Work 12months After the Surgery.
Document number of participants that returned to work 12 months after surgery.
Time frame: 12 months after the surgery
Population: The analyzed subjects at 12 months only included the subjects who had available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MAST™ Procedure | Number of Patients That Returned to Work 12months After the Surgery. | Number of participants working at baseline(N=252) | 79 Participants currently working |
| MAST™ Procedure | Number of Patients That Returned to Work 12months After the Surgery. | Number of participants working at 12 months (N=227 | 97 Participants currently working |
Secondary
Number of Patients Who Utilized Rehabilitation Programs
The number of patients who utilized rehabilitation programs was documented (when required).
Time frame: From 6-12 months after the day of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAST™ Procedure | Number of Patients Who Utilized Rehabilitation Programs | 61 participants |
Secondary
ODI Difference 12 Months After the Surgery as Compared to Baseline.
Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.
Time frame: Baseline, 12 months
Population: The number of analyzed at 12 months only included subjects who had available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST™ Procedure | ODI Difference 12 Months After the Surgery as Compared to Baseline. | Baseline (N=251) | 45.5 Units on a scale | Standard Deviation 15.4 |
| MAST™ Procedure | ODI Difference 12 Months After the Surgery as Compared to Baseline. | 12 Month (N=226) | 22.4 Units on a scale | Standard Deviation 18.8 |
p-value: <0.000195% CI: [-25.5, -20.5]t-test, 2 sided
Secondary
Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).
Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).
Time frame: From baseline until 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAST™ Procedure | Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates). | 3 Participants |
Secondary
Proportion of Patients Needing Intervention at Adjacent Level(s).
Proportion of the patients needing intervention at adjacent level(s).
Time frame: From Baseline until 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAST™ Procedure | Proportion of Patients Needing Intervention at Adjacent Level(s). | 4 Participants |