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

June 11, 2010
April 1, 2014
June 2010
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01143324 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Degenerative Lumbar Spine Causing Back and/or Leg Pain
  • Lumbar Spine Degeneration
Device: MAST™ procedure
Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
MAST™ procedure
Intervention: Device: MAST™ procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
August 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Germany,   Greece,   Israel,   Italy,   Netherlands,   Poland,   Portugal,   Slovakia,   Spain,   United Kingdom
 
NCT01143324
MASTERS-D Study
No
Medtronic Spinal & Biologics ECA
Medtronic Spinal & Biologics ECA
Not Provided
Principal Investigator: Jörg Franke, PD Dr. Klinik für Wirbelsäulenchirurgie; Dortmund
Medtronic Spinal & Biologics ECA
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP