A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier:
NCT01143324
First received: June 11, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.


Condition Intervention
Degenerative Lumbar Spine Causing Back and/or Leg Pain
Lumbar Spine Degeneration
Device: MAST™ procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)

Further study details as provided by Medtronic Spinal & Biologics ECA:

Primary Outcome Measures:
  • To observe and document the patients short term recovery after surgery [ Time Frame: Surgery to discharge ] [ Designated as safety issue: No ]
    The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.


Secondary Outcome Measures:
  • To observe and document clinical and radiological patient's outcomes one year after surgery. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    A series of secondary outcome measures are defined to assess the clinical outcomes, safety profile and fusion rate in long term (12 months).


Enrollment: 255
Study Start Date: June 2010
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MAST™ procedure Device: MAST™ procedure
Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.

Detailed Description:

Instrumented lumbar fusion is usually done through an open procedure which involves an excessive intraoperative dissection and retraction of the paraspinal musculature leading, in a short term basis, to a prolonged recovery time from the surgery. This open approach is frequently associated with significant blood loss and need of transfusion, produces the majority of the perioperative pain, increases hospital stay and the chances of infection and delays the return to normal activities and to work. In a long term basis, the open procedure leads to denervation, atrophy and loss of the muscles independent function, resulting in an increased risk of "fusion disease", a term that has been coined to describe its occurrence.

The minimally invasive spinal surgery was developed as a potential solution to the above-mentioned problems by reducing the amount of iatrogenic soft tissue injury while reaching the same traditional goals of the open procedures. Besides minimizing the long-term effects of exposure-related muscle injury, minimally invasive lumbar fusion techniques hold the promise of immediate short-term advantages. Patients undergoing minimally invasive procedures are reported to recover earlier from the surgery. Shorter time to first ambulation, less pain medication consumption, less blood loss, less required transfusion, shorter hospital stay and earlier return to work are generally associated with the minimally invasive procedure as compared to the standard open surgeries. The minimally invasive access requires a surgical corridor targeted on the disease which is accomplished by using a series of tubular muscle dilators allowing a clear intraoperative visualization to perform these procedures together with the parallel use of image guided percutaneous insertion of pedicle screws and instrumentation.

The purpose of this study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF or TLIF techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient population comprises individuals that have an indication for a single or double level instrumented lumbar fusion for the treatment of the degenerative lumbar spine causing back and/or leg pain.

Patients enrolled in this study will receive a single or double level instrumented fusion using PLIF or TLIF techniques via a MAST™ procedure.

Criteria

Inclusion Criteria:

  • Patient is >18 years of age (or minimum age as required by local regulations).
  • Patient has indication for a single or double level instrumented lumbar fusion for the treatment of the degenerative lumbar spine.
  • 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 B.2 Device Information.
  • Patient is planned to be submitted to the fusion procedure using PLIF or TLIF techniques and to receive a CD HORIZON® Spinal System via a MAST™ approach.
  • The patient is willing and is able to cooperate with study procedures and required follow-up visits.

Exclusion Criteria:

  • Patient that has already undergone an open lumbar spine surgery other than microdiscectomy.
  • Indications for the procedure other than degenerative spine disease like Osteoporotic vertebral fractures, Spine trauma fractures and Spine tumor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143324

Locations
Austria
Klinikum Amstetten
Amstetten, Austria
Belgium
OLV Ziekenhuis
Aalst, Belgium
Canada, New Brunswick
Spine, Sports Medicine and Orthopedic Surgery
Saint John, New Brunswick, Canada
Czech Republic
Karvinska Hornicka Nemocnice
Karvina, Czech Republic
Germany
Klinikum Kulmbach
Kulmbach, Bayern, Germany
Marienhaus Klinikum
Bendorf, Germany
Neurochirurgische Universitatsklinik
Freiburg, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Greece
Mediterraneo
Glyfada, Greece
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Italy
Instituto Ortopedici Rizzoli
Bologna, Italy
Fatebenefratelli Hospital
Milano, Italy
Netherlands
Bergman Clinics
Naarden, Netherlands
Franciscus Ziekenhuis Rosendaal
Rosendaal, Netherlands
Poland
University Clinical Center
Gdansk, Poland
Portugal
Hospital San Joao
Porto, Portugal
Slovakia
Ustredna Vojenska Nemocnica SNP
Ruzomberok, Slovakia
Spain
Hospital Clinic De Barcelona
Barcelona, Spain, 08036
United Kingdom
Guys & St; Thomas NHS Trust
London, United Kingdom
Sponsors and Collaborators
Medtronic Spinal & Biologics ECA
Investigators
Principal Investigator: Jörg Franke, PD Dr. Klinik für Wirbelsäulenchirurgie; Dortmund
  More Information

No publications provided

Responsible Party: Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier: NCT01143324     History of Changes
Other Study ID Numbers: MASTERS-D Study
Study First Received: June 11, 2010
Last Updated: April 1, 2014
Health Authority: Belgium: Ethics Committee
Belgium: Data Protection Authority
Germany: Ethics Commission
Austria: Ethikkommission
Canada: Ethics Review Committee
Czech Republic: Ethics Committee
Israel: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Poland: Ethics Committee
United Kingdom: Research Ethics Committee
Greece: Ethics Committee
Slovak Republic: Ethics Committee

Keywords provided by Medtronic Spinal & Biologics ECA:
Single or double level instrumented fusion
Degenerative lumbar spine
PLIF
TLIF
MAST procedure

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases

ClinicalTrials.gov processed this record on April 14, 2014