A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)

Conditions
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Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration

Intervention / Treatment
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* Device: MAST™ procedure


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria to participate in the study in order to comply with the 'real world' population concept. This observational study does not require any specific test or procedure that falls outside a standard surgical procedure and patient follow-up as routinely done in the hospital. Some data was collected only for centers that applied such procedures as standard of care.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MAST™ procedure<br> | Device: MAST™ procedure<br>* Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From date of Surgery to date of First ambulation, assessed up to hospital discharge. | 
| 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. | From date of surgery until date of surgery recovery day assessed up to hospital discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 12 months | 
| 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. | Baseline, 12 months | 
| 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. | Baseline, 12 months | 
| 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. | 12 months | 
| Number of Patients Who Utilized Rehabilitation Programs | The number of patients who utilized rehabilitation programs was documented (when required). | From 6-12 months after the day of surgery | 
| 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). | From baseline until 12 months | 
| Proportion of Patients Needing Intervention at Adjacent Level(s). | Proportion of the patients needing intervention at adjacent level(s). | From Baseline until 12 months | 
| 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. | Baseline, 12 months | 
| Document Adverse Events Occurrence Throughout the Study. | Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing. | From Baseline until 12 months | 
| 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'. | Baseline, 12 months | 
| Number of Patients That Returned to Work 12months After the Surgery. | Document number of participants that returned to work 12 months after surgery. | 12 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single or double level instrumented fusion, Degenerative lumbar spine, PLIF, TLIF, MAST procedure