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

Lumbar Spine Degeneration Clinical Trial

— MASTERS-D  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143324
• Other study ID #: MASTERS-D Study
• Status: Completed
• Start date: June 2010
• Est. completion date: August 2013

Study information

• Verified date: January 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Lumbar Spine Causing Back and/or Leg Pain
• Lumbar Spine Degeneration
• Spondylarthritis

Intervention

Device:
• MAST™ procedure
Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.

Locations

Country	Name	City	State
Austria	Klinikum Amstetten	Amstetten
Belgium	OLV Ziekenhuis	Aalst
Canada	Spine, Sports Medicine and Orthopedic Surgery	Saint John	New Brunswick
Czechia	Karvinska Hornicka Nemocnice	Karvina
Germany	Marienhaus Klinikum	Bendorf
Germany	Neurochirurgische Universitatsklinik	Freiburg
Germany	Klinikum Kulmbach	Kulmbach	Bayern
Germany	Universitätsklinikum Magdeburg	Magdeburg
Greece	Mediterraneo	Glyfada
Israel	The Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Instituto Ortopedici Rizzoli	Bologna
Italy	Fatebenefratelli Hospital	Milano
Netherlands	Bergman Clinics	Naarden
Netherlands	Franciscus Ziekenhuis Roosendaal	Roosendaal
Poland	University Clinical Center	Gdansk
Portugal	Hospital San Joao	Porto
Slovakia	Ustredna Vojenska Nemocnica SNP	Ruzomberok
Spain	Hospital Clinic De Barcelona	Barcelona
United Kingdom	Guys & St; Thomas NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czechia,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Surgery to First Ambulation.	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.	From date of Surgery to date of First ambulation, assessed up to hospital discharge.
Primary	Time to Surgery Recovery Day.	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.	From date of surgery until date of surgery recovery day assessed up to hospital discharge.
Secondary	Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.	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.	Baseline, 12 months
Secondary	Leg Pain Intensity VAS Score as Compared to Baseline	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.	Baseline, 12 months
Secondary	EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.	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.	Baseline, 12 months
Secondary	Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.	Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.	12 months
Secondary	Number of Patients Who Utilized Rehabilitation Programs	The number of patients who utilized rehabilitation programs was documented (when required).	From 6-12 months after the day of surgery
Secondary	Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).	Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).	From baseline until 12 months
Secondary	Proportion of Patients Needing Intervention at Adjacent Level(s).	Proportion of the patients needing intervention at adjacent level(s).	From Baseline until 12 months
Secondary	Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.	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.	Baseline, 12 months
Secondary	Document Adverse Events Occurrence Throughout the Study.	Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.	From Baseline until 12 months
Secondary	ODI Difference 12 Months After the Surgery as Compared to Baseline.	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'.	Baseline, 12 months
Secondary	Number of Patients That Returned to Work 12months After the Surgery.	Document number of participants that returned to work 12 months after surgery.	12 months after the surgery