A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Lumbar Spine Causing Back and/or Leg Pain
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 255
- Locations
- 19
- Primary Endpoint
- Time to Surgery Recovery Day.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.(Baseline, 12 months)
- Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.(12 months)
- Number of Patients Who Utilized Rehabilitation Programs(From 6-12 months after the day of surgery)
- Proportion of Patients Needing Intervention at Adjacent Level(s).(From Baseline until 12 months)
- Leg Pain Intensity VAS Score as Compared to Baseline(Baseline, 12 months)
- EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.(Baseline, 12 months)
- Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.(Baseline, 12 months)
- Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).(From baseline until 12 months)
- ODI Difference 12 Months After the Surgery as Compared to Baseline.(Baseline, 12 months)
- Document Adverse Events Occurrence Throughout the Study.(From Baseline until 12 months)
- Number of Patients That Returned to Work 12months After the Surgery.(12 months after the surgery)