Lumbar Spine Degeneration Clinical Trial
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.
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.
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