Intervertebral Disc Degeneration
Conditions
Keywords
spondylolisthesis, CD Horizon® Spinal Systems, minimal invasive, Spinal Fusion, MAST procedure, Lumbar fusion
Brief summary
The purpose of this study is * to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I). * To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar Interbody Fusion) are used in surgical practice and to describe long-term safety and effectiveness in a broad patient population of patients with degenerative lumbar disc disease .
Detailed description
In this Prospective, Global (multi center), Post Market Release (PMR) Study, Patients will be submitted to a single or double level instrumented fusion procedure using a PLIF, TLIF, ALIF, OLIF, DLIF or MIDLF technique via a minimally invasive procedure and will receive the same medical treatment as if they would not participate in this study. * The study will be monitored with visits conducted at the start, during and at the closure of the clinical study. * MedDRA coding will be used to classify the Adverse Event. * The study will be conducted according to Medtronic SOPs * Sample size calculation: Assuming that the standard deviation for ODI improvement at 3 months is 20 for both groups (anterolateral and posterior) and there is no difference in the mean ODI improvement at 3 months, with 80% power and 5% alpha level, the sample size for the primary endpoint (DDD patients operated for spondylolisthesis) is as follows in order to claim equivalence between two groups with equivalent margin (-10, 10): * Estimated sample size per group (anterolateral procedures versus posterior procedures): 70 * Estimated total sample size for spondylolisthesis patients: 140 * From the MASTERS-D study it is know that approximately 50% of the patients with degenerative disc disease have spondylolisthesis ≥ grade I. Hence the required total sample size is 140/0.5 = 280. The study is anticipated to enroll 350 patients. * In addition to a final statistical analysis, 3 months and annual interim analyses are anticipated. * The study hypothesis for the primary objective is to verify whether patients operated for spondylolisthesis (≥ grade I) have equivalent mean improvement of ODI at 3 months regardless of the minimally invasive surgical procedure (anterolateral or posterior) used. * The null-hypothesis: Ho: Δ ODI\_Anterolateral ≠ Δ ODI\_posterior * will be tested against the alternative hypothesis: HA: Δ ODI\_Anterolateral = Δ ODI\_posterior Where Δ ODI\_Anterolateral is the average improvement in ODI score (baseline - 3 months) in spondylolisthesis subjects treated with the anterolateral approach and Δ ODI\_posterior is the average improvement in ODI score (baseline - 3 months) in spondylolisthesis subjects treated with the posterior approach.
Interventions
DEVICEMinimally invasive lumbar fusion
Patients will receive a single or double level instrumented fusion using a minimally invasive/MAST™ PLIF, TLIF, DLIF, OLIF, ALIF or MIDLF surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon™ Spinal System, is mandatory in this study and will be either mini-open and/or percutaneous.
Sponsors
Medtronic Spinal and Biologics
Study design
Observational model
COHORT
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 degenerative disc disease and an indication for a single or double level instrumented lumbar fusion for the treatment * 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 Medical Devices of the Clinical Investigation Plan * Patient is planned to be submitted to a minimally invasive fusion procedure using a posterior (PLIF, TLIF, MIDLF) or anterolateral (OLIF, ALIF, DLIF ) technique\* \*For a double level instrumented fusion, the same procedure must be used for both levels. * The patient is willing and is able to perform study procedures and required follow-up visits.
Exclusion criteria
* Patient that has already undergone a lumbar fusion surgery * Patient that has already undergone open lumbar surgery other than standard decompression surgery * Indications for the procedure other than degenerative spine disease like: Osteoporotic vertebral fractures, Spine trauma fractures or Spine tumor * Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment or participants under tutelage) * Concurrent participation in another clinical study that may confound study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis | 3 months | To demonstrate that DDD patients operated for spondylolisthesis fare equally well regardless of the surgical procedure (anterolateral or posterior) performed as measured by the change of ODI at 3 months as compared to baseline. ODI=Oswestry Disability Scale \[0-100\]; higher scores mean a worse outcome Timepoints: Baseline and 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis | 3 months | To evaluate whether DDD patients without spondylolisthesis fare equally well regardless of the surgical procedure (anterolateral or posterior) performed, as measured by Oswestry Disability Index (ODI) at 3 months. Scored \[0-100\]; higher scores mean a worse outcome Timepoints: Baseline and 3 months |
| Change (Preop-postop) in ODI Scores for the Total Population | Through 5 years | To observe the change in ODI scores as compared to baseline through 5 years. The score at baseline gives the baseline score \[0-100\]; the higher the score, the worse the outcome. Additional scores are based on the change from baseline. The higher the score, the greater the improvement. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years |
| Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity | Through 5 years | To observe a change in VAS back pain as compared to baseline through 5 years. At baseline scored on a scale from \[0-10\]; 0 = No pain 10= Worst pain possible. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years |
| Change (Preop-postop) in VAS Leg Pain Intensity | Through 5 years | To observe the change in VAS leg pain as compared to baseline through 5 years. The score at baseline gives the baseline score \[0-10\]; 0 = No pain 10= Worst pain possible. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years |
| Change (Postop-preop) in EQ-5D Index Score | Through 5 years | To observe the change in EuroQol-5 Dimension (EQ-5D) index score as compared to baseline through 5 years. Scored from \[-0.109 to 1\]. A higher score means a better outcome. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years |
| The Neurological Success Rate | 5 years | Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raising. Overall neurological success is 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 baseline evaluation to the time period evaluated. Therefore, if any one element in any section does not stay the same or improve, then a patient was not considered a success for neurological status. |
| Fusion Success | Through 5 years | Fusion success rate was summarized for at 1, 2, 3, 4, 5 year follow-up. If a participant showed fusion success at early time points and non-fusion at a later time point, the fusion status at all earlier points was considered as non-fusion. For 2-level fusion participants, fusion success was defined as achieving fusion at both treated levels. |
| Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study | Through 5 years | To document Secondary Surgeries at index and/or adjacent level(s)throughout the study. When a participant requires additional surgery at the index level(s), it can be an indicator of insufficient outcomes of the initial surgery. Due to the progressive nature of the degenerative lumbar spine, additional surgeries at the index and/or adjacent levels might be required after the initial surgery. To ensure all safety and economic values are collected, the revision surgeries and their complication types and rates will be assessed during the study by the surgeons. For secondary surgery at index levels and/or secondary surgery at adjacent levels, survival analysis was performed to estimate the cumulative event rate up to 5 years. |
| Adverse Events | Through 5 years | Document Adverse Events occurrence throughout the study |
| Amount of Days Needed for First Ambulation | From surgery up to hospital discharge, up to 11 days | To observe and document the days needed for participants to get out of bed and ambulate with or without assistance. Time range: \[0-11\] days |
| Amount of Days Needed to Recover From Surgery | Surgery Recovery Day up to hospital discharge, with a maximum of 46 days | To observe and document the days after the surgery, fulfilling following criteria: * No need for intravenous infusion of analgesic drugs * No ongoing surgery related adverse events impending discharge * No need for nursing care Timeframe: \[0-46\] days The objective of the Surgery Recovery Day assessment is to collect the day when the participant could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the participant's clinical recovery such as social factors or co-morbidity. For the purpose of reporting these parameters the day of the surgery were considered 'D0', the first day after surgery as 'D1', the second day as 'D2' and so on. |
| Healthcare Economics Evaluation "Medications" | Baseline to 5-year follow-up | Healthcare utilization were measured with the following three costs components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program |
| Health Economics Evaluation "Resources" | Through 5 years | Healthcare utilization is measured with the following three cost components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program |
| Health Economics Evaluation "Rehabilitation Program" | Baseline to 5 years | Healthcare utilization is measured with the following three costs components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program |
| Health Economics Evaluation "Operative Time" | Peri-operative | Healthcare utilization is measured with the following three cost components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program |
| Health Economics Evaluation "Estimated Blood Loss" | Peri-operative | Healthcare utilization is measured with the following three cost components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program |
| Health Economics Evaluation "Length of Hospital Stay" | Post-operative, up to 53 days | Healthcare utilization is measured with the following three cost components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program The minimum-maximum time spent at the hospital was \[1-53 days\] |
| Health Economics Evaluation "Total Fluoroscopy Time" | Peri-operative | Healthcare utilization is measured with the following three cost components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program |
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables | Baseline | To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information is summarized for all DDD patients per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF). |
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age | Baseline | To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information is summarized for all DDD patients per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF). |
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height | Baseline | To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information is summarized for all DDD patients per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF). |
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight | Baseline | To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information is summarized for all DDD patients per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF). |
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI | Baseline | To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information is summarized for all DDD patients per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF). |
Countries
Argentina, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, Italy, Mexico, Portugal, Russia, Slovakia, South Korea, Spain, United Kingdom
Participant flow
Pre-assignment details
Of the 361 patient enrolled, twenty-four participants were excluded after pre-op. The reasons for these exclusions were that these 24 participants did not undergo the minimally invasive fusion treatment per CIP
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 11.1 |
| BMI (kg/m^2) | 26.8 kg/m^2 STANDARD_DEVIATION 4.5 |
| Current tobacco use Does not use tobacco | 266 Participants |
| Current tobacco use Uses tobacco | 71 Participants |
| History of spine surgery No | 144 Participants |
| History of spine surgery Yes | 15 Participants |
| Medication use at baseline (Nonopioid) No | 72 Participants |
| Medication use at baseline (Nonopioid) Yes | 121 Participants |
| Medication use at baseline (Opioid) No | 94 Participants |
| Medication use at baseline (Opioid) Yes | 119 Participants |
| Medication use at baseline (Other) No | 81 Participants |
| Medication use at baseline (Other) Yes | 37 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Argentina | 6 participants |
| Region of Enrollment Austria | 14 participants |
| Region of Enrollment Belgium | 0 participants |
| Region of Enrollment Brazil | 7 participants |
| Region of Enrollment China | 48 participants |
| Region of Enrollment Czechia | 0 participants |
| Region of Enrollment Denmark | 1 participants |
| Region of Enrollment France | 28 participants |
| Region of Enrollment Germany | 4 participants |
| Region of Enrollment Italy | 1 participants |
| Region of Enrollment Mexico | 1 participants |
| Region of Enrollment Portugal | 17 participants |
| Region of Enrollment Russia | 12 participants |
| Region of Enrollment Slovakia | 3 participants |
| Region of Enrollment South Korea | 23 participants |
| Region of Enrollment Spain | 39 participants |
| Region of Enrollment United Kingdom | 17 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 64 Participants |
| Working status Employed or independent worker | 127 Participants |
| Working status Not employed | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 164 | 2 / 173 |
| other Total, other adverse events | 56 / 164 | 43 / 173 |
| serious Total, serious adverse events | 58 / 164 | 55 / 173 |
Outcome results
None listed