5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)

NCT02617563 | Completed Results

• 1 other identifier: P15-01
• Study Type: observational
• Target: 361
• Locations: 17 countries
• Sites: 27

Brief 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

Keywords

spondylolisthesis; CD Horizon® Spinal Systems; minimal invasive; Spinal Fusion; MAST procedure; Lumbar fusion

Outcome Measures

Primary Outcomes (1)

• Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis

  To demonstrate that DDD patients operated for spondylolisthesis fare equally well regardless of the surgical procedure (anterolateral or posterior) performed as measured by the change of ODI at 3 months as compared to baseline. ODI=Oswestry Disability Scale \[0-100\]; higher scores mean a worse outcome Timepoints: Baseline and 3 months

  3 months

Secondary Outcomes (23)

• Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis

  3 months

• Change (Preop-postop) in ODI Scores for the Total Population

  Through 5 years

• Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity

  Through 5 years

• Change (Preop-postop) in VAS Leg Pain Intensity

  Through 5 years

• Change (Postop-preop) in EQ-5D Index Score

  Through 5 years

Study Arms (1)

Minimally invasive lumbar fusion

A single or double level instrumented fusion using minimally invasive PLIF, TLIF, MIDLF, DLIF, OLIF, ALIF procedures for the treatment of the degenerative lumbar spine.

Device: Minimally invasive lumbar fusion

Interventions

Minimally invasive lumbar fusion DEVICE

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.

Minimally invasive lumbar fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

361 patients suffering from lumbar degenerative disc disease (DDD) were enrolled over a period of 42 months in 27 sites located in Europe, Latin America, and Asia Pacific.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (27)

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABD, Argentina

Location

Kepler Universitatsklinikum

Linz, 4020, Austria

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Hospital Universitario Cajuru

Curitiba, 80050-350, Brazil

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Shangai Tenth People's Hospital

Shanghai, 200072, China

Location

Nový Hradec Králové

Hradec Králové, 500 05, Czechia

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Hôpital Civil de Strasbourg (NHC)

Eckbolsheim, 67201, France

Location

CHRU de Lille, Hôpital Roger Salengro

Lille, 59037, France

Location

Service de Neurochirurgie la Timone

Marseille, France

Location

Klinikum Magdeburg

Magdeburg, 39130, Germany

Location

A.O. Fatebenefratelli e Oftalmico

Milan, 20123, Italy

Location

Hospital Naval General de Alta Especialidad

Mexico City, 4470, Mexico

Location

Hospital Escala Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar de Sao Joao

Porto, 4200-319, Portugal

Location

Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry

Nizhny Novgorod, 603155, Russia

Location

Scientific Research Institute of Traumatology and Orthopedics

Novosibirsk, 630091, Russia

Location

A-klinik

Bratislava, 82108, Slovakia

Location

Department of Orthopedics, Korea University Ansan Hospital

Ansan, 425-707, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Gyeonggi-do, 10444, South Korea

Location

Department of Neurological Surgery, Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital L'Horta Manises

Valencia, 46026, Spain

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)

Ipswich, IP45PD, United Kingdom

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Medtronic Cranial and Spinal Technologies

bart.heijnen@medtronic.com

+31433566584

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: November 10, 2019
• Study Completion: November 14, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Locations

PT (2); CN (3); FR (3); CZ (1); ES (2); KR (3); RU (2); SL (1); DE (1); AU (1); IT (1); ME (1); BE (1); BR (1); DK (1); GB (2); AR (1)