5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
NCT02617563 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 361
Last updated 2026-01-21
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 .
Conditions
- Intervertebral Disc Degeneration
Interventions
- DEVICE
-
Minimally 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 & Collaborators
-
Medtronic Spinal and Biologics
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2019-11-10
- Completion
- 2024-11-14
Countries
- Argentina
- Austria
- Belgium
- Brazil
- China
- Czechia
- Denmark
- France
- Germany
- Italy
- Mexico
- Portugal
- Russia
- Slovakia
- South Korea
- Spain
- United Kingdom
Study Locations
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