Degenerative Lumbar Spine Causing Back and/or Leg PainMASTERS-DNCT01143324
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
An observational study of Degenerative Lumbar Spine Causing Back and/or Leg Pain and Lumbar Spine Degeneration, run by Medtronic Spinal and Biologics at 19 sites in 14 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
- What is being tested?
- MAST™ procedure
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 19 sitesin 14 countries
- Study dates
- Jun 2010to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 14 countries.
19 sites in 14 countries
Germany4 sites
Marienhaus Klinikum
Bendorf
Neurochirurgische Universitatsklinik
Freiburg im Breisgau
Klinikum Kulmbach
Kulmbach, Bavaria
Universitätsklinikum Magdeburg
Magdeburg
Italy2 sites
Instituto Ortopedici Rizzoli
Bologna
Fatebenefratelli Hospital
Milan
Netherlands2 sites
Bergman Clinics
Naarden
Franciscus Ziekenhuis Roosendaal
Roosendaal
Canada1 site
Spine, Sports Medicine and Orthopedic Surgery
Saint John, New Brunswick
About this study
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)
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.
Read the 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.
- Being tested
- MAST™ procedure
- Keywords
- Single or double level instrumented fusion, Degenerative lumbar spine, PLIF, TLIF, MAST procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAST™ procedureDevice
Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
| Study group | Role | What they receive |
|---|---|---|
| MAST™ procedure | Not described Receives: Device: MAST™ procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of Surgery to date of First ambulation, assessed up to hospital discharge.
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.
Measured: From date of surgery until date of surgery recovery day assessed up to hospital discharge.
Secondary outcomes (11)
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.
Measured: Baseline, 12 months
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.
Measured: Baseline, 12 months
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.
Measured: Baseline, 12 months
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.
Measured: 12 months
Number of Patients Who Utilized Rehabilitation Programs
The number of patients who utilized rehabilitation programs was documented (when required).
Measured: From 6-12 months after the day of surgery
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).
Measured: From baseline until 12 months
Proportion of Patients Needing Intervention at Adjacent Level(s).
Proportion of the patients needing intervention at adjacent level(s).
Measured: From Baseline until 12 months
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.
Measured: Baseline, 12 months
Document Adverse Events Occurrence Throughout the Study.
Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.
Measured: From Baseline until 12 months
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'.
Measured: Baseline, 12 months
Number of Patients That Returned to Work 12months After the Surgery.
Document number of participants that returned to work 12 months after surgery.
Measured: 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Lumbar Spine Causing Back and/or Leg PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Franke, PD Dr., Principal investigator, Klinik für Wirbelsäulenchirurgie; Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143324
- Sponsor's protocol ID
- MASTERS-D Study
- Acronym
- MASTERS-D
- Status last verified
- Jan 2016
- First submitted
- 11 Jun 2010
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01143324
- Acronym / sponsor ID
- MASTERS-D / MASTERS-D Study
- Keywords
- Single or double level instrumented fusion, Degenerative lumbar spine, PLIF, TLIF, MAST procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 19 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAST™ procedure | – | Device: MAST™ procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAST™ procedureSingle or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure. | Device | MAST™ procedure |
Primary outcome
Time From Surgery to First Ambulation.
Time frame: From date of Surgery to date of First ambulation, assessed up to hospital discharge.
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.
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.
11 secondary outcomes
Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.
Time frame: Baseline, 12 months
Leg Pain Intensity VAS Score as Compared to Baseline
Time frame: Baseline, 12 months
EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.
Time frame: Baseline, 12 months
Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.
Time frame: 12 months
Number of Patients Who Utilized Rehabilitation Programs
Time frame: From 6-12 months after the day of surgery
Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).
Time frame: From baseline until 12 months
Proportion of Patients Needing Intervention at Adjacent Level(s).
Time frame: From Baseline until 12 months
Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.
Time frame: Baseline, 12 months
Document Adverse Events Occurrence Throughout the Study.
Time frame: From Baseline until 12 months
ODI Difference 12 Months After the Surgery as Compared to Baseline.
Time frame: Baseline, 12 months
Number of Patients That Returned to Work 12months After the Surgery.
Time frame: 12 months after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Franke, PD Dr. principal investigator
Klinik für Wirbelsäulenchirurgie; Dortmund
19 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spine Causing Back and/or Leg Pain and Lumbar Spine Degeneration, run by Medtronic Spinal and Biologics at 19 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Italy, Netherlands, Austria, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Surgery to First Ambulation. (time frame: From date of Surgery to date of First ambulation, assessed up to hospital discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.