N/A
N=337
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
Intervertebral Disc Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02617563 ↗Enrolled (actual)
337
Serious AEs
33.5%
Results posted
Jan 2026
Primary outcome: Primary: Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis — 23.19; 26.08 change of score on a scale (ODI) — p=0.426
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Minimally invasive lumbar fusion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Spinal and Biologics
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis |
23.19; 26.08 | 0.426 |
| SECONDARY Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis |
13.41; 24.20 | — |
| SECONDARY Change (Preop-postop) in ODI Scores for the Total Population |
46.46; 47.02; 13.27; 17.57; 20.23; 25.43 | — |
| SECONDARY Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity |
6.48; 5.76; 3.48; 3.06; 3.47; 3.25 | — |
| SECONDARY Change (Preop-postop) in VAS Leg Pain Intensity |
6.18; 6.33; 3.79; 4.64; 3.99; 4.76 | — |
| SECONDARY Change (Postop-preop) in EQ-5D Index Score |
0.492; 0.543; 0.209; 0.237; 0.267; 0.285 | — |
| SECONDARY The Neurological Success Rate |
52; 58; 2; 1; 53; 57 | — |
| SECONDARY Fusion Success |
110; 100; 17; 16; 33; 25 | — |
| SECONDARY Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study |
6; 13; 4; 8; 2; 2 | — |
| SECONDARY Adverse Events |
10; 5; 18; 17; 66; 75 | — |
| SECONDARY Amount of Days Needed for First Ambulation |
1.6; 1.9 | — |
| SECONDARY Amount of Days Needed to Recover From Surgery |
4.4; 5.0 | — |
| SECONDARY Healthcare Economics Evaluation "Medications" |
121; 101; 43; 72; 70; 49 | — |
| SECONDARY Health Economics Evaluation "Resources" |
2.2; 3.6; 1.8; 2.2 | — |
| SECONDARY Health Economics Evaluation "Rehabilitation Program" |
9; 6; 154; 167; 22; 21 | — |
| SECONDARY Health Economics Evaluation "Operative Time" |
3.371; 2.860 | — |
| SECONDARY Health Economics Evaluation "Estimated Blood Loss" |
148.2; 296.3 | — |
| SECONDARY Health Economics Evaluation "Length of Hospital Stay" |
6.6; 7.5 | — |
| SECONDARY Health Economics Evaluation "Total Fluoroscopy Time" |
144.8; 143.5 | — |
| SECONDARY To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables |
20; 27; 53; 11; 43; 49 | — |
| SECONDARY To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age |
49.4; 59.5; 60.5; 54.5; 61.3; 59.8 | — |
| SECONDARY To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height |
169.4; 167.5; 162.3; 167.3; 164.0; 164.2 | — |
| SECONDARY To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight |
77.2; 82.3; 71.4; 80.9; 75.2; 69.4 | — |
| SECONDARY To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI |
26.8; 29.4; 27.0; 28.9; 27.7; 25.6 | — |
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 .
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02617563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.