"Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has."

Margaret Mead
Original article
peer-reviewed

MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up



Abstract

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.



Want to read more?

Create a free account to continue reading this article.

Already a member? Login.



Original article
peer-reviewed

MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up


Author Information

Neil Manson

Horizon Health Network

David Buzek

Karvinska hornicka nemocnice

Arkadiusz Kosmala

Orthopedics, Klinikum Kulmbach

Ulrich Hubbe

Faculty of Medicine, University of Freiburg, Germany, Neurosurgical Clinic, Medical Center, University of Freiburg, Germany

Wout Rosenberg

Orthopedics, Franciscus Ziekenhuis, Rosendaal

Paulo Pereira

Faculty of Medicine of the University of Porto

Centro Hospitalar São João

Roberto Assietti

Neurosurgery, Fatebenefratelli Hospital

Frederic Martens

Orthopedics, Ons Lieve Vrouw Ziekenhuis

Khai Lam

Spine surgery, London Bridge Hospital, London, UK

Giovanni Barbanti Brodano

Istituto Ortopedico Rizzoli, Bologna, Italy

Peter Durny

Neurosurgery, Ustredna vojenska nemocnica SNP, Ruzomberok, Slovakia

Zvi Lidar

Neurosurgery, The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Kai Scheufler

Neurosurgery, Klinikum Dortmund

Wolfgang Senker

Klinikum Amstetten


Ethics Statement and Conflict of Interest Disclosures

Human subjects: Consent was obtained by all participants in this study. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: Grant from Medtronic for my institution for 15000 dollars.
Fees for participating in review activities such as data monitoring boards, statistical analysis, end point committees etc. from Medtronic for 2000 dollars. Financial relationships: Joerg Franke declare(s) employment from Paradigm. Speaking/teaching arrangements for 15000 dollars. Joerg Franke declare(s) personal fees from Zimmer. Speaking/teaching arrangements for 10000 dollars. Joerg Franke declare(s) personal fees from Philipps. Speaking/teaching arrangements for 2500 dollars. Joerg Franke declare(s) Money to institution from Baxter. Research support for 50000 dollar. Joerg Franke declare(s) Money to Institution from Paradigm Spine. Research support for 25000 dollar. Arkadiusz Kosmala,
Wout Rosenberg,
Frederic Martens,
Khai Lam,
Peter Durny declare(s) Did not receive any payment or service from a 3rd party for any aspect of the submitted work. from Nothing to declare. Has no financial interests with entities as described in the ICMJE instructions. Zvi Lidar declare(s) For participating in review activities such as data monitoring boards, statistical analysis, end point committees etc. for 3000 dollars from Tel Aviv Medical Center. Fees to my institution. Joerg Franke,
Neil Manson,
David Buzek,
Ulrich Hubbe,
Roberto Assietti,
Kai-Michael Scheufler,
Wolfgang Senker declare(s) a grant, personal fees, employment and Money to institution (Scientific advisory board/other office) Research support for 15000 dollar from Medtronic. Consulting for 5000 dollars (J.F)
Speaking/teaching arrangements for 30000 dollars (J.F)
Scientific advisory board/other office for 2000 dollar (J.F)
Speaking/teaching arrangements less than 10000 dollar/year (N.M)
Scientific advisory board, non-financial and financial support less than 10000 dollar (N.M)
Research support, Employment, research co-ordinator salary (N.M)
Consulting Fees, 15800 dollar (D.B)
Consulting fees (U.H)
Speaking/teaching arrangements (U.H)
Trips/Travel (U.H)
Research support for 500 dollars. (U.H)
Speaking/teaching arrangement for 10000 dollars (R.A)
Personal fees for travel and meetings for 3500 dollars (K.S)
Consulting fees for 3000 dollars (K.S)
Speaking/teaching arrangements for 15000 dollars (K.S)
Travel to instructional locations for 1000 dollars (W.S)
Speaking/teaching arrangements for 500 dollars (W.S). Paulo Pereira declare(s) personal fees from Depuy. Consulting fees from Depuy for 1500 dollars. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Acknowledgements

The authors wish to thank the remaining MASTERS-D investigators for their contribution to this study: Prof. Dr. Salvador Fuster, Spain; Dr. Walter Richter, Germany; Dr. Marcus Schröder, The Netherlands; Prof. Pawel Sloniewski, Poland; Dr. Vassilios Vougioukas, Greece; the Medtronic clinical study managers Christel Van Dam and Dr Cristina Faria for conducting the MASTERS-D study; medical affairs managers Dr Alexander Cristea, Dr. Kirstin Demesmaeker, scientific communications specialist Dr Mayra Mori for technical review of the manuscript. The authors would like to thank Bert Parmet and Jacques Janssen of Cromsource for performing the statistical analysis and Carol Berry and Pippa Clarke of Quintiles for medical writing and editorial assistance, which were both funded by Medtronic.


Original article
peer-reviewed

MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up


Figures etc.

Share
Original article
peer-reviewed

MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up

  • Author Information
    Jörg Franke Corresponding Author

    Klinikum Dortmund

    Neil Manson

    Horizon Health Network

    David Buzek

    Karvinska hornicka nemocnice

    Arkadiusz Kosmala

    Orthopedics, Klinikum Kulmbach

    Ulrich Hubbe

    Faculty of Medicine, University of Freiburg, Germany, Neurosurgical Clinic, Medical Center, University of Freiburg, Germany

    Wout Rosenberg

    Orthopedics, Franciscus Ziekenhuis, Rosendaal

    Paulo Pereira

    Faculty of Medicine of the University of Porto

    Centro Hospitalar São João

    Roberto Assietti

    Neurosurgery, Fatebenefratelli Hospital

    Frederic Martens

    Orthopedics, Ons Lieve Vrouw Ziekenhuis

    Khai Lam

    Spine surgery, London Bridge Hospital, London, UK

    Giovanni Barbanti Brodano

    Istituto Ortopedico Rizzoli, Bologna, Italy

    Peter Durny

    Neurosurgery, Ustredna vojenska nemocnica SNP, Ruzomberok, Slovakia

    Zvi Lidar

    Neurosurgery, The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

    Kai Scheufler

    Neurosurgery, Klinikum Dortmund

    Wolfgang Senker

    Klinikum Amstetten


    Ethics Statement and Conflict of Interest Disclosures

    Human subjects: Consent was obtained by all participants in this study. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: Grant from Medtronic for my institution for 15000 dollars.
    Fees for participating in review activities such as data monitoring boards, statistical analysis, end point committees etc. from Medtronic for 2000 dollars. Financial relationships: Joerg Franke declare(s) employment from Paradigm. Speaking/teaching arrangements for 15000 dollars. Joerg Franke declare(s) personal fees from Zimmer. Speaking/teaching arrangements for 10000 dollars. Joerg Franke declare(s) personal fees from Philipps. Speaking/teaching arrangements for 2500 dollars. Joerg Franke declare(s) Money to institution from Baxter. Research support for 50000 dollar. Joerg Franke declare(s) Money to Institution from Paradigm Spine. Research support for 25000 dollar. Arkadiusz Kosmala,
    Wout Rosenberg,
    Frederic Martens,
    Khai Lam,
    Peter Durny declare(s) Did not receive any payment or service from a 3rd party for any aspect of the submitted work. from Nothing to declare. Has no financial interests with entities as described in the ICMJE instructions. Zvi Lidar declare(s) For participating in review activities such as data monitoring boards, statistical analysis, end point committees etc. for 3000 dollars from Tel Aviv Medical Center. Fees to my institution. Joerg Franke,
    Neil Manson,
    David Buzek,
    Ulrich Hubbe,
    Roberto Assietti,
    Kai-Michael Scheufler,
    Wolfgang Senker declare(s) a grant, personal fees, employment and Money to institution (Scientific advisory board/other office) Research support for 15000 dollar from Medtronic. Consulting for 5000 dollars (J.F)
    Speaking/teaching arrangements for 30000 dollars (J.F)
    Scientific advisory board/other office for 2000 dollar (J.F)
    Speaking/teaching arrangements less than 10000 dollar/year (N.M)
    Scientific advisory board, non-financial and financial support less than 10000 dollar (N.M)
    Research support, Employment, research co-ordinator salary (N.M)
    Consulting Fees, 15800 dollar (D.B)
    Consulting fees (U.H)
    Speaking/teaching arrangements (U.H)
    Trips/Travel (U.H)
    Research support for 500 dollars. (U.H)
    Speaking/teaching arrangement for 10000 dollars (R.A)
    Personal fees for travel and meetings for 3500 dollars (K.S)
    Consulting fees for 3000 dollars (K.S)
    Speaking/teaching arrangements for 15000 dollars (K.S)
    Travel to instructional locations for 1000 dollars (W.S)
    Speaking/teaching arrangements for 500 dollars (W.S). Paulo Pereira declare(s) personal fees from Depuy. Consulting fees from Depuy for 1500 dollars. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

    Acknowledgements

    The authors wish to thank the remaining MASTERS-D investigators for their contribution to this study: Prof. Dr. Salvador Fuster, Spain; Dr. Walter Richter, Germany; Dr. Marcus Schröder, The Netherlands; Prof. Pawel Sloniewski, Poland; Dr. Vassilios Vougioukas, Greece; the Medtronic clinical study managers Christel Van Dam and Dr Cristina Faria for conducting the MASTERS-D study; medical affairs managers Dr Alexander Cristea, Dr. Kirstin Demesmaeker, scientific communications specialist Dr Mayra Mori for technical review of the manuscript. The authors would like to thank Bert Parmet and Jacques Janssen of Cromsource for performing the statistical analysis and Carol Berry and Pippa Clarke of Quintiles for medical writing and editorial assistance, which were both funded by Medtronic.


    Article Information

    Published: June 13, 2016

    DOI

    10.7759/cureus.640

    Cite this article as:

    Franke J, Manson N, Buzek D, et al. (June 13, 2016) MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up. Cureus 8(6): e640. doi:10.7759/cureus.640

    Publication history

    Received by Cureus: March 13, 2016
    Peer review began: March 30, 2016
    Peer review concluded: June 07, 2016
    Published: June 13, 2016

    Copyright

    © Copyright 2016
    Franke et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 3.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

    License

    This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

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.



Want to read more?

Create a free account to continue reading this article.

Already a member? Login.