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

Intervertebral Disc Degeneration Clinical Trial

— MASTERS-D2  

Official title:

A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02617563
• Other study ID #: P15-01
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 365
• Est. completion date: December 2025
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Austria	Kepler Universitatsklinikum	Linz
Belgium	AZ Delta	Roeselare
Brazil	Hospital Universitario Cajuru	Curitiba
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Shangai Tenth People's Hospital	Shanghai
Czechia	Nový Hradec Králové	Hradec Králové
Denmark	Glostrup Hospital	Glostrup
France	Hôpital Civil de Strasbourg (NHC)	Eckbolsheim
France	Service de Neurochirurgie la Timone	Marseille
Germany	Klinikum Magdeburg	Magdeburg
Italy	A.O. Fatebenefratelli e Oftalmico	Milan
Korea, Republic of	Department of Orthopedics, Korea University Ansan Hospital	Ansan
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Gyeonggi-do
Korea, Republic of	Department of Neurological Surgery, Chung-Ang University Hospital	Seoul
Mexico	Hospital Naval General de Alta Especialidad	Mexico City
Portugal	Hospital Escala Braga	Braga
Portugal	Centro Hospitalar de Sao Joao	Porto
Russian Federation	Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry	Nizhny Novgorod
Russian Federation	Scientific Research Institute of Traumatology and Orthopedics	Novosibirsk
Slovakia	A-klinik	Bratislava
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital L'Horta Manises	Valencia
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)	Ipswich

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  China,  Czechia,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Mexico,  Portugal,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of disability, Oswestry Disability Index (ODI) 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 improvement of ODI at 3 months as compared to baseline.	3 months
Secondary	Improvement of disability ODI as compared to baseline in DDD patients without spondylolisthesis	To evaluate whether DDD patients without spondylolisthesis fare equally well regardless of the surgical procedure (anterolateral or posterior) performed, as measured by ODI at 3 months	3 months
Secondary	Improvement of ODI	To observe the improvement of ODI as compared to baseline through 5 years	Through 5 years
Secondary	Improvement of Visual analog scale (VAS) back pain intensity	To observe the improvement of VAS back pain as compared to baseline through 5 years	Through 5 years
Secondary	Improvement of VAS leg pain intensity	To observe the improvement of VAS leg pain as compared to baseline through 5 years	Through 5 years
Secondary	Improvement of EQ-5D	To observe the improvement of EQ-5D as compared to baseline through 5 years.	Through 5 years
Secondary	The neurological success rate defined as maintenance or improvement of neurological functions	Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raising.; Overall neurological success will be defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the baseline evaluation to the time period evaluated. Therefore, if any one element in any section does not stay the same or improve, then a patient will not be considered a success for neurological status.	Through 5 years
Secondary	Fusion success	To observe the Fusion success. Fusion success rate will be summarized for at 1, 2, 3, 4, 5 year follow-up. If a subject shows fusion success at early time points and non-fusion at a later time point, the fusion status at all earlier points should be considered as non-fusion. For 2-level fusion subjects, fusion success will be defined as achieving fusion at both treated levels.	Through 5 years
Secondary	Proportion of patients needing a second surgery at the index and/or adjacent level(s) (reoperation rates) throughout the study	Document Secondary Surgeries at index and/or adjacent level(s)throughout the study. When a patient requires additional surgery at the index level(s), it can be an indicator of insufficient outcomes of the initial surgery. Due to the progressive nature of the degenerative lumbar spine, additional surgeries at the index and/or adjacent levels might be required after the initial surgery. To ensure all safety and economic values are collected, the revision surgeries and their complication types and rates will be assessed during the study by the surgeons.; For secondary surgery at index levels and/or secondary surgery at adjacent levels, survival analysis will be performed to estimate the cumulative event rate up to 5 years.	Through 5 years
Secondary	Adverse Events	Document Adverse Events occurrence throughout the study	Through 5 years
Secondary	Amount of days needed for first ambulation	To observe and document the days needed for patient to get out of bed and ambulate with or without assistance	From surgery up to hospital discharge
Secondary	Amount of days needed to recover from Surgery	To observe and document the days after the surgery, fulfilling following criteria: No need for intravenous infusion of analgesic drugs; No ongoing surgery related adverse events impending discharge; No need for nursing care; The objective of the Surgery Recovery Day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors or co-morbidity.; For the purpose of reporting these parameters the day of the surgery will be considered 'D0', the first day after surgery as 'D1', the second day as 'D2' and so on.	Surgery Recovery Day up to hospital discharge
Secondary	Health economics evaluation	Healthcare utilization will be measured with the following three costs components: resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc); medications; non-pharmacologic therapies: rehabilitation program	Through 5 years
Secondary	Comparison of Patient profile at baseline with minimally invasive fusion procedure performed	To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information will be summarized for all DDD patients and by subgroups as outlined below and/or per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF).; In DDD patients with spondylolisthesis and stenosis; In DDD patients with spondylolisthesis without stenosis; In DDD patients with stenosis without spondylolisthesis; All patients not included in subgroup 1), 2), 3).	Baseline to surgery