EuroSpine 2015 COPENHAGEN, DENMARK

Transcription

1 Ulrich Hubbe*1, Roberto Assietti2 Khai Lam3, Hamid Khoshab4, Kai Scheufler5, Salvador Fuster6, Joerg Franke7 1. Universitätsklinikum Freiburg* 2 Ospedale Benefratelli, Milano, 3 Guy's and St Thomas' NHS Hospitals London, 4Central Military hospital (UVN), Ruzomberok,, 5 Hospital zum Heiligen Geist Kempen, 6 Hospital Clínic de Barcelona, Barcelona, 7 Otto von Guericke University of Magdeburg EuroSpine 2015 COPENHAGEN, DENMARK

2 MASTERS-D Study Design and Objective Multi-center, Prospective, Post-market, Observational NCT Med Hx Pain Meds Demographics Work status (WS) EQ-D QoL Surgery VAS, Pain Meds, AEs 255 pts from 19 sites / 14 countries Indication: Single or double level MIS fusion procedure with CD Horizon Spinal System using PLIF or TLIF for treatment of degenerative lumbar spine QoL, Pain Meds, AEs, Rehab, WS, Pt Satisf. QoL, Pain Meds AEs, Rehab, WS, Pt Satisf, Imaging FPI: 24 Jun 2010 LPI: 24 Aug 2011 BL SUR DIS 4W 3M 6M 252pts 249pts 244pts 241pts 1YR 233pts Primary Endpoint: Short term recovery after surgery (Time to 1st ambulation and Surgery Recovery Day=potential release) Secondary endpoints: Clinical and radiological outcomes one year after surgery. Pereira P, Buzek D, Franke J, Senker W, Kosmala A, et al. (2015) Surgical Data and Early Postoperative Outcomes after Minimally Invasive Lumbar Interbody Fusion: Results of a Prospective, Multicenter, Observational Data-Monitored Study. PLoS ONE 10(3): e doi: /journal.pone

3 Patient demographics primary population Demographics Main pathologies Baseline Characteristics N patients = 252 Mean (SD) Gender (Females) 56.3% Mean Age in years 53.8 (11.8) BMI 27.7 (4.6) 52.8% 71.4% 93.7% Duration of symptoms resulting in surgery in months 28.5 (38.2) Duration of conservative treatment in months 20.7 (34.3) 8.3% Pre-existing conditions relevant to study 37.3% Previous lumbar surgeries At target level: Microdiscectomy Open Surgery Microdiscectomy Minimal Invasive Surg. Decompression 18.7% 15.1% 3.2% 9.1% 3.6% Spondylolisthesis Disc pathology Other Pereira P, Buzek D, Franke J, Senker W, Kosmala A, et al. (2015) Surgical Data and Early Postoperative Outcomes after Minimally Invasive Lumbar Interbody Fusion: Results of a Prospective, Multicenter, Observational Data-Monitored Study. PLoS ONE 10(3): e doi: /journal.pone

4 Objectives Main pathologies, n= % 71.4% 52.8% 8.3% Subpopulation analysis, n=180 To investigate whether primary and secondary outcomes of MILIF for DLD were different between: Patients with stenosis (n=180) vs patients without stenosis (n=72) Stenotic patients with decompression (n=142) vs Stenotic patients indirect decompression (n=38) Spondylolisthesis Disc pathology Other Primary dataset from a multicenter 1-year prospective observational study (MASTERSD; NCT ) Primary Outcomes Time needed for first ambulation (days) Time to post-surgical recovery (days) Clinical Secondary Outcomes (baseline to 4 weeks and 12 months) ODI pre/post-surgery VAS leg pain VAS back pain Medians and Interquartile ranges (IQR) are shown; Statistics: Mann Whitney U-test

5 Primary endpoints: No stenosis vs with decompression vs indirect decompression patients take longer to recover (2 days) but the majority of patients ambulate within 1 day

6 Primary endpoints: with decompression vs indirect decompression Indirectly decompressed patients take longer to recover but both patient groups ambulate within a day

7 Secondary Clinical endpoints vs Non- patients Higher VAS Leg Pain scores in patients at baseline (p=0.0014) Equally low VAS Leg Pain scores in versus Non- patients at 12-months Difference of VAS Leg pain between Stenosi s No Bl and 4w Bl and 12m p Change from baseline to 4 w and 12 mo was more pronounced in patients (p=0.0185) Mann-Whitney U-test; n.s. = not significant

8 Secondary Clinical endpoints vs Non- patients ODI VAS Back pain Difference of ODI between No stenosis p Difference of VAS Back pain between No p Bl and 4w Bl and 12m Bl and 4w Bl and 12m There was a trend of higher ODI improvement in the stenosis group, however this was not statistically significant Decompression vs Indirect decompression No statistical differences among the subgroups stenosis decompression x indirect decompression from baseline to 4 weeks and 12 months in regards to ODI, VAS Leg pain nor VAS back pain

9 Low number of MILIF-related adverse events/serious adverse events AEs surgery, device or MILIF (12 MILIF (2 surgery, device or MILIF (3 MILIF (0 surgery, device or MILIF (24 MILIF (1 patient) No stenosis Aes stenosis indirectly decompressed Aes stenosis decompressed SAEs 4,5 5 3,5 4 2,5 3 1,5 2 0,5 1 0 surgery, device or MILIF (5 MILIF (1 surgery, device or MILIF (0 patient) MILIF (0 patient) surgery, device or MILIF (3 MILIF (0 patient) No stenosis Aes stenosis indirectly decompressed Aes stenosis decompressed

10 General Conclusions Stenotic patients suffer more leg pain at baseline Decompression improves the surgery recovery MILIF and Better improvement of leg pain Low morbidity

11 Acknowledgements MASTERS-D study investigators Drs Franke, Pereira, Senker, Manson, Franke, Buzek, Kosmala, Rosenberg, Assietti, Martens, Lam, Barbanti, Durny, Lidar, Richter, Sloniewski, Fuster, Vougioukas, Schroder and PC member Dr Scheufler. All patients who participated in the study, staff who contributed to the conduct of the study and Medtronic Spinal & Biologics

12 Conflict of Interest Disclosure All authors participated of the MASTERS-D clinical trial which was sponsored by Medtronic U. Hubbe: Consultancy Medtronic R Assietti: No conflict of interest K Lam: No conflict of interest H Khoshab: No conflict of interest S Fuster: No conflict of interest K Scheufler: Consultancy Medtronic J Franke: Consultancy Medtronic