Clinical trial NCT01143324: A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Spine Causing Back and/or Leg Pain
Lumbar Spine Degeneration
Keywords: Single or double level instrumented fusion
Degenerative lumbar spine
PLIF
TLIF
MAST procedure
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Time From Surgery to First Ambulation.
timeFrame: From date of Surgery to date of First ambulation, assessed up to hospital discharge.
measure: Time to Surgery Recovery Day.
timeFrame: From date of surgery until date of surgery recovery day assessed up to hospital discharge.
Secondary outcomes:
measure: Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.
timeFrame: Baseline, 12 months
measure: Leg Pain Intensity VAS Score as Compared to Baseline
timeFrame: Baseline, 12 months
measure: EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.
timeFrame: Baseline, 12 months
measure: Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.
timeFrame: 12 months
measure: Number of Patients Who Utilized Rehabilitation Programs
timeFrame: From 6-12 months after the day of surgery
measure: Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).
timeFrame: From baseline until 12 months
measure: Proportion of Patients Needing Intervention at Adjacent Level(s).
timeFrame: From Baseline until 12 months
measure: Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.
timeFrame: Baseline, 12 months
measure: Document Adverse Events Occurrence Throughout the Study.
timeFrame: From Baseline until 12 months
measure: ODI Difference 12 Months After the Surgery as Compared to Baseline.
timeFrame: Baseline, 12 months
measure: Number of Patients That Returned to Work 12months After the Surgery.
timeFrame: 12 months after the surgery
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Klinikum Amstetten
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Saint John
country: Canada
facility: Spine, Sports Medicine and Orthopedic Surgery
state: New Brunswick
city: Karvina
country: Czechia
facility: Karvinska Hornicka Nemocnice
city: Kulmbach
country: Germany
facility: Klinikum Kulmbach
state: Bayern
city: Bendorf
country: Germany
facility: Marienhaus Klinikum
city: Freiburg
country: Germany
facility: Neurochirurgische Universitatsklinik
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Glyfada
country: Greece
facility: Mediterraneo
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Instituto Ortopedici Rizzoli
city: Milano
country: Italy
facility: Fatebenefratelli Hospital
city: Naarden
country: Netherlands
facility: Bergman Clinics
city: Roosendaal
country: Netherlands
facility: Franciscus Ziekenhuis Roosendaal
city: Gdansk
country: Poland
facility: University Clinical Center
city: Porto
country: Portugal
facility: Hospital San Joao
city: Ruzomberok
country: Slovakia
facility: Ustredna Vojenska Nemocnica SNP
city: Barcelona
country: Spain
facility: Hospital Clinic De Barcelona
city: London
country: United Kingdom
facility: Guys & St; Thomas NHS Trust
Study officials:
affiliation: Klinik für Wirbelsäulenchirurgie; Dortmund
name: Jörg Franke, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: