PMID- 27433419
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160719
LR  - 20200930
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 8
IP  - 6
DP  - 2016 Jun 13
TI  - MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, 
      Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar 
      Disorders, One-Year Follow-Up.
PG  - e640
LID - 10.7759/cureus.640 [doi]
LID - e640
AB  - The objective of the study is to assess effectiveness and safety of minimally 
      invasive lumbar interbody fusion (MILIF) for degenerative lumbar disorders (DLD) 
      in daily surgical practice and follow up with patients for one year after 
      surgery. A prospective, multicenter, pragmatic, monitored, international outcome 
      study in patients with DLD causing back/leg pain was conducted (19 centers). Two 
      hundred fifty-two patients received standard of care available in the centers. 
      Patients were included if they were aged >18 years, required one- or two-level 
      lumbar fusion for DLD, and met the criteria for approved device indications. 
      Primary endpoints: time to first ambulation (TFA) and time to surgery recovery 
      (TSR). Secondary endpoints: patient-reported outcomes (PROs)--back and leg pain 
      (visual analog scale), disability (Oswestry Disability Index (ODI)), health 
      status (EQ-5D), fusion rates, reoperation rates, change in pain 
      medication, rehabilitation, return to work, patient satisfaction, and adverse 
      events (AEs). Experienced surgeons (>/=30 surgeries pre-study) treated patients 
      with DLD by one- or two-level MILIF and patients were evaluated for one 
      year (NCT01143324). At one year, 92% (233/252) of patients remained in the study. 
      PRIMARY OUTCOMES: TFA, 1.3 +/-0.5 days and TSR, 3.2 +/-2.0 days. SECONDARY OUTCOMES: 
      Most patients (83.3%) received one level MILIF; one (two-level) MILIF mean 
      surgery duration, 128 (182) min; fluoroscopy time, 115 (154) sec; blood loss, 164 
      (233) mL; at one year statistically significant (P<.0001) and clinically 
      meaningful changes from baseline were reported in all PROs--reduced back pain 
      (2.9 +/-2.5 vs. 6.2 +/-2.3 at intake), reduced leg pain (2.2 +/-2.6 vs. 5.9 +/-2.8), and 
      ODI (22.4% +/- 18.6 vs. 45.3% +/- 15.3), as well as health-related quality of life 
      (EQ-5D index: 0.71 +/-0.28 vs. 0.34 +/-0.32). More of the professional workers were 
      working at one year than those prior to surgery (70.3% vs. 55.2%). Three AEs and 
      one serious AE were considered procedure-related; there were no deep site 
      infections or deaths. This is the first study evaluating MILIF for treatment of 
      DLD in daily clinical practice. Clinically significant improvements were observed 
      in all endpoints. Short-term post-surgery improvements (four weeks) were 
      maintained through one year with minimal complications. Our results suggest that 
      MILIF has good-to-excellent outcomes for the treatment of DLD in a broad patient 
      population under different clinical conditions and healthcare delivery systems.
FAU - Franke, Jorg
AU  - Franke J
AD  - Klinikum Dortmund.
FAU - Manson, Neil
AU  - Manson N
AD  - Horizon Health Network.
FAU - Buzek, David
AU  - Buzek D
AD  - Karvinska hornicka nemocnice.
FAU - Kosmala, Arkadiusz
AU  - Kosmala A
AD  - Orthopedics, Klinikum Kulmbach.
FAU - Hubbe, Ulrich
AU  - Hubbe U
AD  - Faculty of Medicine, University of Freiburg, Germany, Neurosurgical Clinic, 
      Medical Center, University of Freiburg, Germany.
FAU - Rosenberg, Wout
AU  - Rosenberg W
AD  - Orthopedics, Franciscus Ziekenhuis, Rosendaal.
FAU - Pereira, Paulo
AU  - Pereira P
AD  - Faculty of Medicine of the University of Porto ; Centro Hospitalar Sao Joao.
FAU - Assietti, Roberto
AU  - Assietti R
AD  - Neurosurgery, Fatebenefratelli Hospital.
FAU - Martens, Frederic
AU  - Martens F
AD  - Orthopedics, Ons Lieve Vrouw Ziekenhuis.
FAU - Lam, Khai
AU  - Lam K
AD  - Spine surgery, London Bridge Hospital, London, UK.
FAU - Barbanti Brodano, Giovanni
AU  - Barbanti Brodano G
AD  - Istituto Ortopedico Rizzoli, Bologna, Italy.
FAU - Durny, Peter
AU  - Durny P
AD  - Neurosurgery, Ustredna vojenska nemocnica SNP, Ruzomberok, Slovakia.
FAU - Lidar, Zvi
AU  - Lidar Z
AD  - Neurosurgery, The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
FAU - Scheufler, Kai
AU  - Scheufler K
AD  - Neurosurgery, Klinikum Dortmund.
FAU - Senker, Wolfgang
AU  - Senker W
AD  - Klinikum Amstetten.
LA  - eng
PT  - Journal Article
DEP - 20160613
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC4945329
OTO - NOTNLM
OT  - degenerative lumbar disorders
OT  - minimal access spinal technologies
OT  - minimally invasive lumbar fusion
OT  - patient-reported outcomes
OT  - pragmatic
COIS- The authors have declared financial relationships, which are detailed in the next 
      section.
EDAT- 2016/07/20 06:00
MHDA- 2016/07/20 06:01
PMCR- 2016/06/13
CRDT- 2016/07/20 06:00
PHST- 2016/07/20 06:00 [entrez]
PHST- 2016/07/20 06:00 [pubmed]
PHST- 2016/07/20 06:01 [medline]
PHST- 2016/06/13 00:00 [pmc-release]
AID - 10.7759/cureus.640 [doi]
PST - epublish
SO  - Cureus. 2016 Jun 13;8(6):e640. doi: 10.7759/cureus.640.