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5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
Sponsor: Medtronic Spinal and Biologics
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 .
Official title: A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
361
Start Date
2015-12
Completion Date
2024-11-14
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
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.
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
CHRU de Lille, Hôpital Roger Salengro
Lille, France
Service de Neurochirurgie la Timone
Marseille, France
Klinikum Magdeburg
Magdeburg, Germany
A.O. Fatebenefratelli e Oftalmico
Milan, Italy
Hospital Naval General de Alta Especialidad
Mexico City, Mexico
Hospital Escala Braga
Braga, Portugal
Centro Hospitalar de Sao Joao
Porto, Portugal
Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry
Nizhny Novgorod, Russia
Scientific Research Institute of Traumatology and Orthopedics
Novosibirsk, Russia
A-klinik
Bratislava, Slovakia
Department of Orthopedics, Korea University Ansan Hospital
Ansan, South Korea
National Health Insurance Corporation Ilsan Hospital
Gyeonggi-do, South Korea
Department of Neurological Surgery, Chung-Ang University Hospital
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital L'Horta Manises
Valencia, Spain
Hull Royal Infirmary
Hull, United Kingdom
East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)
Ipswich, United Kingdom