Currently the available data on cost and clinical effectiveness of TLIF compared to PLIF for patients with lumbar spondylolisthesis is not sufficient. With a steep increase in instrumented spinal fusion, and an expected further increase in the…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine change in Oswestry Disability Index. This can be obtained by
completing the ODI-questionnaire pre- and postoperatively. This functional
score is a tool for measuring patients permanent functional disability,
specially designed for patients with low back related disabilities.
To determine change in quality of life adjusted years (QALY) with EQ-5D-5L,
measured pre- and postoperatively. The EQ-5D-5L is a questionnaire to
determine the quality-adjusted life years associated with a health state.
Secondary outcome
- Hospital Anxiety Depression Scale (HADS): To determine the pre-operative
anxiety and depression level with the use of HADS, a fourteen item scale,
consisting of a 7-item depression scale and a 7-anxiety scale. The score range
from 0-21 with a high score being indicative for depression/anxiety.
- Short Form (36) Health Survey: To determine change in a patient-reported
survey of patient health (physical and social status) consisting of 8 domains:
Physical functioning, physical role functioning, emotional role functioning,
vitality, mental health, social functioning, bodily pain and general health
perceptions. Each domain is scored on a 0-100 scale, the higher the score the
less disability.
- Visual Analogue Scale (VAS) score of back pain and leg pain: To determine
change in back and leg pain assessed on a horizontal 10 cm visual scale,
varying from 0 cm (no pain) to 10 cm (worst pain imaginable).
- To compare the number and kind of complications (defined as; dural tear,
postoperative infection, hematoma, hardware failure, neurological deficits,
medical other complications as pneumonia or urinary tract infection) between
both procedures, peri- and postoperatively.
- To determine clinical outcome by pre-operative and postoperative physical
examination. Muscle strength of the legs classified with the MRC scale,
sensibility in dermatomes classified into normally present, changed and absent,
reflexes in the lower extremities.
- Cost effectivity of both procedures determined with productivity related
costs(iPCQ) and medical costs(iMCQ).*
Background summary
Low back pain, with or without leg pain, is a common complaint in the general
population. It causes disability and health care problems in the work force,
and hereby a large economic burden on society. In the Netherlands back (and
neck) complaints are responsible for 25% of health care costs for
musculoskeletal disease (1.5% of total health care budget) (RIVM).
The lifetime prevalence of developing low back pain is 70%. The reporting of
the prevalence of accompanying leg pain (sciatica) varies greatly with a range
of 1.2-43%. In few cases these complaints are caused by lumbar
spondylolisthesis (incidence of spondylolisthesis in adult population being
approximately 6%). If conservative treatment, consisting of brace support, pain
medication, physiotherapy or manual therapy fails, surgical treatment can be
considered.
The aim of surgery is to treat leg pain that is caused by compression or
stretch of neurogenic structures. Instrumented spinal fusion is the preferred
surgical treatment for these indications, and is more and more commonly used;
in the US, between 1998 and 2008 the national bill for instrumented spinal
fusion increased 7.9-fold. This increase is also expected in the Netherlands
(RIVM). Currently XX surgical treatments are executed every year in the
Netherlands.
Various instrumented spinal fusion techniques have been described; PLIF was
introduced in 1953 by. TLIF is a modification of PLIF introduced. Over the
years several other variations as ALIF, XLIF etc. have been developed, still
for the same indications.
In case of isthmic spondylolisthesis, leg pain is generally caused by
compression and stretch of the exiting nerve root at the isthmic level, uni- or
bilaterally. In case of degenerative spondylolisthesis, leg symptoms are
generally caused by compression of the cauda equina/nerve roots in the spinal
canal resulting in neurogenic claudication (Syndrome of Verbiest). Surgery aims
at decompressing neurogenic structures, by means of laminectomy of the proximal
level involved in the listhesis. To prevent progression of listhesis
decompression is accompanied by lumbar pedicle screw fixation and spinal fusion
using interbody cage or cages.
The TLIF procedure consists of placement of one cage in the intervertebral
space, using a unilateral approach at the side where nerve root complaints are
most severe. Due to the *banana* shape of the cage, it can be placed in the
midline and is assumed to decompress the contra-lateral nerve root as well. The
PLIF procedure consists of placement two identical cages bilaterally in the
intervertebral space using a bilateral approach.
Currently both techniques are world wide standard care. There are no strict
indications for using either techniques, nor is literature (low-quality
observational reports) in this matter conclusive. As a result the choice for
technique is based on a surgeon*s experience and preference.
A number of cohort studies have shown that both methods effectively reduce leg
pain. Non-randomized studies suggest that TLIF is associated with fewer
complications, less blood loss, shorter surgical time and shorter hospital
duration, perhaps related to unilateral, less invasive character of the
procedure. These findings have not been confirmed in a randomized controlled
trial (RCT).
Therefore TLIF should be the preferred technique of choice: 1. Surgical
morbidity rates are in favor of TLIF, 2. Direct (surgical) costs for TLIF
appear lower, 3. Indirect costs are in favor of TLIF, 4. Clinical outcome is
effective for both techniques.
This study proposes to analyze in a high quality design (multicenter, patient
blinded, randomized controlled trial) the cost-effectiveness of the TLIF
technique compared to PLIF technique for patients with intermittent neurogenic
claudication and/or mono uni-or bilateral lumbar radiculopathy caused by single
level degenerative, isthmic or iatrogenic spondylolisthesis.
Study objective
Currently the available data on cost and clinical effectiveness of TLIF
compared to PLIF for patients with lumbar spondylolisthesis is not sufficient.
With a steep increase in instrumented spinal fusion, and an expected further
increase in the future, there is a need for comparative data to develop
evidence based treatment recommendations. The current guidelines do not advise
which is the most appropriate surgical treatment strategy for these patients.
The results of this study will provide surgical treatment recommendations for
patients with lumbar spondylolisthesis and contribute to the understanding of
its short- and long-term clinical postoperative course. *
Study design
Multicenter, patient blinded, randomized controlled trial.
Intervention
Transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar
interbody fusion (PLIF).
Study burden and risks
All mentioned questionnaires are currently standard care for this surgical
procedure in our hospital. Only the questionnaires for economical evaluation
are additional. Patients are expected to invest 20 minutes per follow up moment
extra for this (in total 5x over 2 years, pre-operatively, at 3 months, 6
months, 12 months and 24 months). The risks are standard risks associated with
this surgical procedure, this is not research dependent.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
1. Indication for TLIF (transforaminal lumbar interbody fusion) of PLIF
(posterior lumbar interbody fusion) surgery.
2. Clinical mono uni-or bilateral lumbar radiculopathy or intermittent
neurogenic claudication caused by a single level isthmic, degenerative or
iatrogenic spondylolisthesis gr I, II or III according to Meyerding
classification at level L3L4, L4L5 or L5S1.
3. Age over 18 years.
4. Single level spondylolisthesis with central or foraminal stenosis on MRI (or
CT), of which the anatomical level is corresponding to the clinical syndrome.
5. Psychosocially, mentally, and physically able to fully comply with this
study protocol.
6. Informed consent prior to this study., Inclusioncriteria of informal
caregivers of patients:
1. The patient where the ICG offers his care, has to participate in the
LIFT-study.
2. Age over 18 years
3. Psychosocially, mentally, and physically able to fully comply with this
study protocol.
4. Informed consent prior to this study.
Exclusion criteria
1. Previous radiotherapy at the intended surgical level.
2. (Progressive) motor failure and/or anal sphincter disorders which urges
instant intervention.
3. Active spinal infection.
4. Immature bone (on-going growth).
5. Active malignancy.
6. Pregnancy.
7. Symptomatic osteoporosis (based on DEXA-scan).
8. Contra-indications for anaesthesia or surgery.
9. Inadequate command of the Dutch language., Exclusioncriteria of informal
caregivers of patients:
1. Inadequate command of the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54717.096.16 |