Clinical trial NCT02617563: 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
Official title: A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Degeneration
Keywords: spondylolisthesis
CD Horizon® Spinal Systems
minimal invasive
Spinal Fusion
MAST procedure
Lumbar fusion
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 365 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.

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 .

Detailed description: 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 (DDD patients operated for spondylolisthesis) is as follows in order to claim equivalence between two groups with equivalent margin (-10, 10):
* Estimated sample size per group (anterolateral procedures versus posterior procedures): 70
* Estimated total sample size for spondylolisthesis patients: 140
* 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 140/0.5 = 280. The study is anticipated to enroll 350 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.

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.

Primary outcomes:
measure: Improvement of disability, Oswestry Disability Index (ODI) as compared to baseline in DDD patients with spondylolisthesis
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of disability ODI as compared to baseline in DDD patients without spondylolisthesis
timeFrame: 3 months
measure: Improvement of ODI
timeFrame: Through 5 years
measure: Improvement of Visual analog scale (VAS) back pain intensity
timeFrame: Through 5 years
measure: Improvement of VAS leg pain intensity
timeFrame: Through 5 years
measure: Improvement of EQ-5D
timeFrame: Through 5 years
measure: The neurological success rate defined as maintenance or improvement of neurological functions
timeFrame: Through 5 years
measure: Fusion success
timeFrame: Through 5 years
measure: Proportion of patients needing a second surgery at the index and/or adjacent level(s) (reoperation rates) throughout the study
timeFrame: Through 5 years
measure: Adverse Events
timeFrame: Through 5 years
measure: Amount of days needed for first ambulation
timeFrame: From surgery up to hospital discharge
measure: Amount of days needed to recover from Surgery
timeFrame: Surgery Recovery Day up to hospital discharge
measure: Health economics evaluation
timeFrame: Through 5 years
measure: Comparison of Patient profile at baseline with minimally invasive fusion procedure performed
timeFrame: Baseline to surgery
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Linz
country: Austria
facility: Kepler Universitatsklinikum
city: Roeselare
country: Belgium
facility: AZ Delta
city: Curitiba
country: Brazil
facility: Hospital Universitario Cajuru
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Shanghai
country: China
facility: Shangai Tenth People's Hospital
city: Hradec Králové
country: Czechia
facility: Nový Hradec Králové
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Eckbolsheim
country: France
facility: Hôpital Civil de Strasbourg (NHC)
city: Marseille
country: France
facility: Service de Neurochirurgie la Timone
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
city: Milan
country: Italy
facility: A.O. Fatebenefratelli e Oftalmico
city: Ansan
country: Korea, Republic of
facility: Department of Orthopedics, Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Neurological Surgery, Chung-Ang University Hospital
city: Mexico City
country: Mexico
facility: Hospital Naval General de Alta Especialidad
city: Braga
country: Portugal
facility: Hospital Escala Braga
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry
city: Novosibirsk
country: Russian Federation
facility: Scientific Research Institute of Traumatology and Orthopedics
city: Bratislava
country: Slovakia
facility: A-klinik
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital L'Horta Manises
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Ipswich
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)
Study officials:
References: