5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)

Medtronic Spinal and Biologics361 enrolled

Overview

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 .

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (27)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Kepler Universitatsklinikum

Linz, Austria

AZ Delta

Roeselare, Belgium

Hospital Universitario Cajuru

Curitiba, Brazil

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Shangai Tenth People's Hospital

Shanghai, China

Nový Hradec Králové

Hradec Králové, Czechia

Glostrup Hospital

Glostrup Municipality, Denmark

Hôpital Civil de Strasbourg (NHC)

Eckbolsheim, France

...and 17 more locations

Outcomes

Primary Outcomes

Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis

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

Time frame: 3 months

Secondary Outcomes

Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis

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

Time frame: 3 months

Change (Preop-postop) in ODI Scores for the Total Population

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

Time frame: Through 5 years

Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity

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

Time frame: Through 5 years

Change (Preop-postop) in VAS Leg Pain Intensity

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

Time frame: Through 5 years

Change (Postop-preop) in EQ-5D Index Score

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

Time frame: Through 5 years

The Neurological Success Rate

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.

Time frame: 5 years

Fusion Success

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.

Time frame: Through 5 years

Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study

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.

Time frame: Through 5 years

Adverse Events

Document Adverse Events occurrence throughout the study

Time frame: Through 5 years

Amount of Days Needed for First Ambulation

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

Time frame: From surgery up to hospital discharge, up to 11 days

Amount of Days Needed to Recover From Surgery

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.

Time frame: Surgery Recovery Day up to hospital discharge, with a maximum of 46 days

Healthcare Economics Evaluation "Medications"

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

Time frame: Baseline to 5-year follow-up

Health Economics Evaluation "Resources"

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

Time frame: Through 5 years

Health Economics Evaluation "Rehabilitation Program"

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

Time frame: Baseline to 5 years

Health Economics Evaluation "Operative Time"

Time frame: Peri-operative

Health Economics Evaluation "Estimated Blood Loss"

Time frame: Peri-operative

Health Economics Evaluation "Length of Hospital Stay"

Time frame: Post-operative, up to 53 days

Health Economics Evaluation "Total Fluoroscopy Time"

Time frame: Peri-operative

To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables

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).

Time frame: Baseline

To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age

Time frame: Baseline

To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height

Time frame: Baseline

To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight

Time frame: Baseline

To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI

Time frame: Baseline

5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)

Overview

Conditions

Interventions

Eligibility

Locations (27)

Outcomes

Primary Outcomes

Secondary Outcomes