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: September 4, 2014
Last verified: September 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:
  • Time From Surgery to First Ambulation. [ Time Frame: From date of Surgery to date of First ambulation, assessed up to hospital discharge. ] [ Designated as safety issue: No ]

    The primary objective of the study is to access the short term recovery (from surgery to hospital 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.

    Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital.


  • Time to Surgery Recovery Day. [ Time Frame: From date of surgery until date of surgery recovery day assessed up to hospital 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.

    Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs 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.



Secondary Outcome Measures:
  • Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

    Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).

    The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain.


  • Leg Pain Intensity VAS Score as Compared to Baseline [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

    Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).

    The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain.


  • EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent's self-rated health on a vertical 20 cm VAS where the endpoints are labelled 'Best imaginable health state' at the top and 'Worst imaginable health state' at the bottom, having numeric values of 100 and 0 respectively.

  • Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.

  • Number of Patients Who Utilized Rehabilitation Programs [ Time Frame: From 6-12 months after the day of surgery ] [ Designated as safety issue: No ]
    The number of patients who utilized rehabilitation programs was documented (when required).

  • Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates). [ Time Frame: From baseline until 12 months ] [ Designated as safety issue: No ]
    Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).

  • Proportion of Patients Needing Intervention at Adjacent Level(s). [ Time Frame: From Baseline until 12 months ] [ Designated as safety issue: No ]
    Proportion of the patients needing intervention at adjacent level(s).

  • Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.

  • Document Adverse Events Occurrence Throughout the Study. [ Time Frame: From Baseline until 12 months ] [ Designated as safety issue: Yes ]
    Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.

  • ODI Difference 12 Months After the Surgery as Compared to Baseline. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.

  • Number of Patients That Returned to Work 12months After the Surgery. [ Time Frame: 12 months after the surgery ] [ Designated as safety issue: No ]
    Document number of participants that returned to work 12 months after surgery.


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.

In order to reduce as much as possible bias in this observational study, the study centers should propose the study to all consecutive individuals who meet these in and exclusion criteria to participate in the study in order to comply with the 'real world' population concept. This observational study does not require any specific test or procedure that falls outside a standard surgical procedure and patient follow-up as routinely done in the hospital. Some data was collected only for centers that applied such procedures as standard of care.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: May 23, 2014
Last Updated: September 4, 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 September 30, 2014