A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

2015-12-02 00:53:25 | BioPortfolio


The purpose of this study is

- to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in 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 is as follows in order to claim equivalence between two groups with equivalent margin (-7.5, 7,5):

- Estimated sample size per group (anterolateral procedures versus posterior procedures): 122

- Estimated total sample size for spondylolisthesis patients: 244

- 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 244/0.5 = 488. The study is anticipated to enroll 560 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervertebral Disc Degeneration


Minimally invasive lumbar fusion


Service de Neurochirurgie la Timone


Not yet recruiting


Medtronic Spinal & Biologics ECA

Results (where available)

View Results


Published on BioPortfolio: 2015-12-02T00:53:25-0500

Clinical Trials [2076 Associated Clinical Trials listed on BioPortfolio]

Trunk Muscles and Lumbar Intervertebral Disc Degeneration in Combat Sports

This study examined whether there is an association between the presence of lumbar intervertebral disc degeneration (LDD) and the size and symmetry of the cross-sectional areas (CSAs) of t...

Effect of Abaloparatide on Lumbar Disc Degeneration

Low back pain is a major public health issue as the leading cause of disability globally. Degeneration of intervertebral disc (IVD) disorder is once source of low back pain. Current treatm...

Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction

This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia. The current study is prospective pilot clinical study to...

A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement

Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc ...

PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation

Lumbar disc herniation (LDH) is a common and frequently-occurring disease giving rise to low back pain and (or) leg pain. There are about 1.5 million people with LDH-related pain, accounti...

PubMed Articles [6081 Associated PubMed Articles listed on BioPortfolio]

Electroacupuncture down-regulates expression of ADAMTS-4 of intervertebral disc in rats with lumbar intervertebral disc degeneration.

To observe the effect of electroacupuncture (EA) stimulation on the levels of a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4) protein in the lumbar intervertebral disc tiss...

Adjacent Intervertebral Disc Height Decrease Phenomenon after Single-Level Transforaminal Lumbar Interbody Fusion (TLIF) of Lumbar Spine.

The increase of intradiscal pressure on the upper segment results from the intervertebral distraction after lumbar intervertebral fusion decreases the intervertebral height and aggravates the degenera...

Severe lumbar intervertebral disc degeneration is associated with Modic changes and fatty infiltration in the paraspinal muscles at all lumbar levels, except L1-L2: A cross-sectional analysis of 50 symptomatic females and age-matched 50 symptomatic males.

Low back pain is a common public health problem associated with lumbar intervertebral disc degeneration. It is still unclear, whether intervertebral disc degeneration is an isolated process or accompa...

Percutaneous endoscopic lumbar discectomy and minimally invasive transforaminal lumbar interbody fusion for massive lumbar disc herniation.

To compare the clinical outcomes of patients with massive lumbar disc disease undergoing percutaneous endoscopic lumbar discectomy and minimally invasive transforaminal lumbar interbody fusion at a si...

MiR-532 downregulation of the Wnt/β-catenin signaling via targeting Bcl-9 and induced human intervertebral disc nucleus pulposus cells apoptosis.

Intervertebral disc degeneration was characterized with aberrant intervertebral disc nucleus pulposus cells apoptosis. MiR-532 was reported to be up-regulated in the patients with intervertebral disc ...

Medical and Biotech [MESH] Definitions

The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.

An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.

Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.

Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.

The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.

More From BioPortfolio on "A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine"

Quick Search


Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...

Searches Linking to this Trial