EVALUATION OF THE EFFICACY, SAFETY, EFFECTIVENESS AND EFFICIENCY
OF THE USE OF ARTIFICIAL IMPLANTS TO SURGICALLY FIX LUMBAR
VERTEBRA
Title.
The effectiveness of instrumented arthrodesis
versus non-instrumented in the surgical treatment of symptomatic
spinal stenosis: a systematic review of the scientific literature.
Background.
The treatment of low back pain includes a
wide variety of methods and varies from one setting to another.
One of the reasons for this diversity could be the uneven
quality and quantity of available studies on the efficacy
and effectiveness of the treatments used. In fact, there are
systematic reviews of the scientific literature that determine
the solidity (or absence thereof) of the basis for the use
of several common treatments for low back pain, such as medications,
bed rest, back schools, exercise, massage, TENS, traction,
vertebral manipulation, acupuncture, behavioral therapy, multidisciplinary
rehabilitation, neuroreflexotherapy, different kinds of infiltrations
including epidurals, surgery for disc hernia and surgery for
spondylosis.
However, a review of the scientific evidence of certain treatments
commonly used in the Spanish National Health System for the
treatment of mechanical pathologies of the spine should be
made in order to optimize their effectiveness and efficiency.
Thus, for example, in patients in whom two vertebra are to
be fixed (that is to say, who are to receive a "vertebral
arthrodesis"), this fixation can be achieved using a
fragment of bone (usually from the patient's own iliac crest),
"non-instrumented arthrodesis"-or using different
kinds of metal implants ("instrumented arthrodesis").
The studies made to compare the results of instrumented versus
non-instrumented vertebral arthrodesis are of an uneven scientific
quality. Currently there is no systematic review that allows
one to draw a solid conclusion about it, and this is not only
important from a clinical point of view, due to the potential
morbidity and mortality associated with the procedure, but
also due to the considerable difference in costs the choice
of one procedure over another entails for the National Health
System.
Objective.
To find and analyze the existing scientific
literature on the effectiveness of instrumented versus non-instrumented
arthrodesis in the surgical treatment of symptomatic lumbar
spinal stenosis and summarize it in a solid recommendation.
Methodology.
It was a systematic review and meta-analysis
of the scientific literature. All of the randomized clinical
trials comparing instrumented and non-instrumented arthrodesis
were identified.
To find these studies, electronic and additional search strategies
were used in order to identify potential studies that had
not been gathered in these bases.
The methodological quality of each one of the studies found
was studied and a sensitivity analysis was conducted to explore
the possible relation between the quality and the results
of each study. The evaluation of the scientific quality of
each study included aspects of methodological quality (such
as those relating to the design of the clinical trial in accordance
with the established standards of the international scientific
community), and clinical or technical quality (related to
the use of the different surgical techniques and the selection
of their appropriateness, as was described in each study).
The scientific quality of each study was appraised by two
independent reviewers in order to guarantee greater rigor
in their appraisals. In the cases where they disagreed, a
joint discussion was held and a final consensus was reached,
with the contribution of the rest of the researchers in those
cases where needed.
The characteristics of all the identified clinical trials
were described structurally and an overall appraisal of the
effect of the surgery was made by means of the OR (odds ratio)
or when the studied effecters were very frequent, using the
RR (relative risk), calculated by means of the Revman or Stata
programs. Both the absolute measures of the effect as well
as the necessary number of patients to treat in order to observe
the desired effect (NNT) were calculated.
Participants, along with the Foundation's
Science Department.
Cochrane Iberoamerican Center and the Department
of Rheumatological Rehabilitation at the Hospital Ramón
y Cajal.
The study was co-funded by the Fund for Health Research (FIS)
and the Kovacs Foundation.
Status.
In progress.
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