Posterior lumbar interbody fusion is an open surgical technique that has been widely used for the treatment of degenerative lumbar disease. However, traditional lumbar spinal fusion, especially long-segment fusion surgery, is associated with several complications. The IntraSPINE (Cousin Biotech, Wervicq-Sud, France) is a new device for non-fusion lumbar spine surgery that is used as an alternative for the treatment of degenerative lumbar disease. Although the designer of the IntraSPINE proposed indications for its use, including combination of the device with lumbar spinal fusion for the treatment of degenerative lumbar disease, use of the IntraSPINE has not been reported in the clinical literature. In the present case, we boldly combined the IntraSPINE device and posterior lumbar interbody fusion for the treatment of skipped-level lumbar disc herniation to explore the indications of the IntraSPINE and report its clinical outcomes.
Posterior lumbar interbody fusion is an open surgical technique that has been widely used for the treatment of degenerative lumbar disease. However, traditional lumbar spinal fusion, especially long-segment fusion surgery, is associated with several complications. The IntraSPINE (Cousin Biotech, Wervicq-Sud, France) is a new device for non-fusion lumbar spine surgery that is used as an alternative for the treatment of degenerative lumbar disease. Although the designer of the IntraSPINE proposed indications for its use, including combination of the device with lumbar spinal fusion for the treatment of degenerative lumbar disease, use of the IntraSPINE has not been reported in the clinical literature. In the present case, we boldly combined the IntraSPINE device and posterior lumbar interbody fusion for the treatment of skipped-level lumbar disc herniation to explore the indications of the IntraSPINE and report its clinical outcomes.
Posterior lumbar interbody fusion (PLIF) has been widely used for the treatment of various
degenerative lumbar diseases because of its biomechanical stability and high rates of
successful fusion.[1] However, complications after lumbar spinal fusion, including lumbar motor
dysfunction, lumbar stiffness, and intractable low back pain, have been recently reported.[2] Notably, adjacent segment disease (ASD) is considered one of the most serious
long-term complications of spinal arthrodesis.[3] Clinical research has shown that the incidence of ASD ranges from 3.9% to 41.0%[4]; using only radiographic criteria, however, the incidence ranges from 8% to
100%.[5,6]Skipped-level disc degeneration (SLDD) is the unique occurrence of lumbar disc degeneration
with healthy/normal discs between degenerated discs on magnetic resonance imaging (MRI).[7] The underreporting of SLDD in the literature throughout the years indirectly suggests
that this pattern of disc degeneration is less symptomatic than contiguous multilevel disc degeneration.[8] The surgical techniques used for contiguous multilevel disc degeneration may not be
suitable for SLDD.Considering the potential complications after lumbar spinal fusion, non-fusion lumbar spine
surgery is becoming a research hotspot. Tachibana et al.[9] proposed that non-fusion devices that provide dynamic stabilization might offer new
solutions for prevention of ASD. Different kinds of non-fusion devices for dynamic
stabilization, including Wallis, Isobar, Coflex, and X-Stop, have been reported.[10] However, all of these are interspinous devices rather than interlaminar devices.The IntraSPINE (Cousin Biotech, Wervicq-Sud, France) is a new interlaminar dynamic
stabilization device that was designed by Giancarlo Guizzardi and first used in the clinical
setting in 2007. The core material of the IntraSPINE is flexible medical silica gel, and the
surface material is polyester fiber, which can enlarge the foramina, relieve the pressure on
facets and discs, and stabilize the spine without sacrificing its natural motion (Figure 1). In his report, Guizzardi[11] stated that the indications for use of the IntraSPINE were low back pain caused by
disc degeneration, lumbar instability, young patients after lumbar discectomy, and chronic
low back pain caused by zygapophyseal joint syndromes, among others. Although the
indications for the IntraSPINE were proposed by the designer, some of them (e.g., back pain
caused by disc degeneration and combination of the device with lumbar spinal fusion) have
not been reported in the clinical literature.
Figure 1.
(a) Dorsal surface of IntraSPINE. (b) Ventral surface of IntraSPINE. (c, d) Placement
location of IntraSPINE in the spine model. (e) Intraoperative image. The arrow indicates
the location of the IntraSPINE.
(a) Dorsal surface of IntraSPINE. (b) Ventral surface of IntraSPINE. (c, d) Placement
location of IntraSPINE in the spine model. (e) Intraoperative image. The arrow indicates
the location of the IntraSPINE.In the present case report, we describe a patient with lumbar SLDD who underwent treatment
with a combination of the IntraSPINE device and PLIF. This case report may help in exploring
new indications for IntraSPINE that have been infrequently discussed in the literature.
Case presentation
A 64-year-old woman presented with a 10-year history of lumbago. Her symptoms had worsened
during the most recent 6 months, with radiating pain in the front aspect of both thighs and
posterolateral aspect of both shanks. She also exhibited intermittent neurogenic
claudication while walking within 100 m. Preoperative physical examination demonstrated
normal results of the bilateral femoral nerve stretch test and bilateral straight leg raise
test. The patient also had hypesthesia, which was mainly distributed in the front aspect of
both thighs, posterolateral aspect of both shanks, and both soles. Her bilateral muscle
strength and sensation were normal, as were her bilateral patellar reflexes and Achilles
tendon reflexes.Dynamic X-ray imaging of the lumbar spine confirmed instability of the L4–5 disc space, and
the posterior disc height (PDH) at the L2–3 level was 6.3 mm. The range of motion at the
L2–3 level was 14.2°, showing instability (>11°) in the L2–3 motion segment (Figure 2). T2- and T1-weighted sagittal
MRI of the lumbar region showed lumbar canal stenosis at the L2–3, L4–5, and L5–S1 levels.
T2-weighted axial images showed marked stenosis at the L2–3, L4–5, and L5–S1 levels (Figure 3). The patient was finally
diagnosed with lumbar disc herniation (L2–3, L4–5, and L5–S1), lumbar spinal stenosis, and
lumbar spondylolisthesis (L4–5).
Figure 2.
Preoperative X-ray examination. (a–d) Preoperative dynamic X-ray examination indicated
instability of the L4–5 vertebral body. The range of motion at the L2–3 level was 14.2°
(15.1°− 0.9° = 14.2°). (e) The posterior disc height at the L2–3 level was 6.3 mm.
Figure 3.
Preoperative magnetic resonance imaging (MRI). (a, b) T2- and T1-weighted sagittal MRI
of the lumbar region showed lumbar canal stenosis at the L2–3, L4–5, and L5–S1 levels.
(c–f) T2-weighted axial images showed marked stenosis at the L2–3, L4–5, and L5–S1
levels. The width of the L3–4 lumbar canal was acceptable. (a): T1-weighted MRI. (b)
T2-weighted MRI. (c) L2–3 level. (d) L3–4 level. (e) L4–5 level. (f) L5–S1 level.
Preoperative X-ray examination. (a–d) Preoperative dynamic X-ray examination indicated
instability of the L4–5 vertebral body. The range of motion at the L2–3 level was 14.2°
(15.1°− 0.9° = 14.2°). (e) The posterior disc height at the L2–3 level was 6.3 mm.Preoperative magnetic resonance imaging (MRI). (a, b) T2- and T1-weighted sagittal MRI
of the lumbar region showed lumbar canal stenosis at the L2–3, L4–5, and L5–S1 levels.
(c–f) T2-weighted axial images showed marked stenosis at the L2–3, L4–5, and L5–S1
levels. The width of the L3–4 lumbar canal was acceptable. (a): T1-weighted MRI. (b)
T2-weighted MRI. (c) L2–3 level. (d) L3–4 level. (e) L4–5 level. (f) L5–S1 level.Preoperative L3 nerve root blockade was performed to confirm whether the L2–3 level was the
responsible segment. The radiating pain in the front aspect of both thighs was relieved
after the L3 nerve root blockade; i.e., the L2–3 level was verified as the responsible
segment requiring treatment.After obtaining an accurate diagnosis, the patient underwent PLIF with decompression at the
L4–5 and L5–S1 segments, internal fixation with a pedicle screw system, and fusion with a
bone graft. To ensure a satisfying outcome of decompression, we destructed the lamina and
facet joint, which necessitated destruction of the posterior column integrity at the L5–S1
level. Thus, we performed fixation and fusion at the L5–S1 level. At the L2–3 segment, we
implanted the IntraSPINE device without decompression.Preoperatively, the visual analog scale (VAS) score for lower back pain was 7 points and
that for both lower limbs was 8 points. Postoperatively, the VAS score for lower back pain
was 3 points and that for both lower limbs was 2 points. The patient was encouraged to
exercise her lower back muscles on the bed after the drainage tube was removed 2 days
postoperatively. When her muscle strength had recovered, the patient was requested to stand
and walk with the help of a brace 5 days postoperatively. Three months after the operation,
the patient’s back pain, radiating pain of both lower limbs, and neurogenic claudication
symptoms had completely disappeared. The hypesthesia of the front aspect of both thighs,
posterolateral aspect of both shanks, and both soles was also relieved to some degree.Postoperative X-ray and computed tomography examinations revealed that the pedicle screw
system used for internal fixation was in the pedicle area and that the location of the
IntraSPINE device was suitable. As shown in Figure 4(e), the anterior part of the IntraSPINE was attached to the ligamentum
flavum, which effectively enlarged the interlaminar space. The PDH at the L2–3 level was 7.1
mm (Figure 4).
Figure 4.
Postoperative (a–c) X-ray and (d–h) computed tomography (CT) examinations revealed that
the pedicle screw system used for internal fixation was in the pedicle area, that the
location of the IntraSPINE was suitable, and the posterior disc height at the L2–3 level
was 7.1 mm. The red arrow indicates the location of the IntraSPINE. (a) Frontal X-ray
views. (b). Lateral X-ray views. (c) The posterior disc height at the L2–3 level was 7.1
mm. (d) Sagittal CT. (e) Axial CT at the L2–3 level showed that the location of the
IntraSPINE was suitable. (f) L4 vertebral body. (g) L5 vertebral body. (h) S1 vertebral
body.
Postoperative (a–c) X-ray and (d–h) computed tomography (CT) examinations revealed that
the pedicle screw system used for internal fixation was in the pedicle area, that the
location of the IntraSPINE was suitable, and the posterior disc height at the L2–3 level
was 7.1 mm. The red arrow indicates the location of the IntraSPINE. (a) Frontal X-ray
views. (b). Lateral X-ray views. (c) The posterior disc height at the L2–3 level was 7.1
mm. (d) Sagittal CT. (e) Axial CT at the L2–3 level showed that the location of the
IntraSPINE was suitable. (f) L4 vertebral body. (g) L5 vertebral body. (h) S1 vertebral
body.Fourteen months after the operation, follow-up X-ray examination showed that the location
of the IntraSPINE in the L2–3 segment had not moved and that the PDH at the L2–3 level was
7.0 mm. The range of motion at the L2–3 level was 7.1°, which indicated instability
(>11°) before the operation. MRI showed disc degeneration at the L2–3 level without
obvious aggravation (Figure 5).
Figure 5.
(a–c) Follow-up X-ray examination 14 months after the operation showed that the
location of the IntraSPINE at the L2–3 segment had not moved, and magnetic resonance
imaging showed disc degeneration at the L2–3 level without obvious aggravation. (a)
Lateral X-ray views. The posterior disc height at the L2–3 level was 7.0 mm. (b, c) The
range of motion at the L2–3 level was 7.1° (9.0°−1.9° = 7.1°). (d) T2-weighted sagittal
images. (e) T2-weighted axial images at the L2–3 level.
(a–c) Follow-up X-ray examination 14 months after the operation showed that the
location of the IntraSPINE at the L2–3 segment had not moved, and magnetic resonance
imaging showed disc degeneration at the L2–3 level without obvious aggravation. (a)
Lateral X-ray views. The posterior disc height at the L2–3 level was 7.0 mm. (b, c) The
range of motion at the L2–3 level was 7.1° (9.0°−1.9° = 7.1°). (d) T2-weighted sagittal
images. (e) T2-weighted axial images at the L2–3 level.
Discussion
The unique occurrence of noncontiguous disc degeneration or SLDD of the lumbar spine, which
is characterized by healthy/normal discs between degenerated discs on MRI, has been
previously described.[7] The reported prevalence of SLDD is 8.1% and 20.0% in the overall population and among
individuals with multilevel disc degeneration, respectively.[12] Certainly, PLIF is the optimal solution for the treatment of SLDD.However, complications of PLIF have been reported, such as massive trauma, excessive
bleeding, and extensive posterior column destruction of the spine.[13] Fan et al.[14] reported that PLIF requires a much higher load to maintain lumbar stability than do
non-fusion techniques, thus increasing the incidence of ASD. Cheh et al.[15] considered that the length of fusion is a significant risk factor for the development
of ASD, and the risk of fusion up to the L1–3 level was higher than that at L4 and L5 in
their 5-year follow-up study. Moreover, long-segment fusion also increases the risk of more
severe trauma, more bleeding, more extensive posterior column destruction of the spine, and
complications related to instrumentation.[16] Zheng et al.[17] indicated that the number of levels fused seemed to be the most significant factor
predicting the hospital stay, operative time, intraoperative blood loss, and requirement for
transfusion.Interspinous spacers are typically representative of non-fusion techniques and include the
Wallis, Coflex, X-Stop, and other similar devices.[10,18] These are used as alternatives to PLIF in
treating degenerative lumbar spinal disease.[19] Interspinous spacers unload the facet joints, enlarge the interspinous space, and
reduce the intradiscal pressure in extension by distracting the spinous processes.[20] However, complications of interspinous spacers have been described, including
incorrect positioning, intraoperative spinous process fracture, spinous process fatigue
fracture, supraspinous ligament rupture, and difficult implantation at the L5–S1
level.[21,22]In contrast to interspinous spacers, the IntraSPINE is a new kind of interlaminar device[23] that can significantly improve the functional status in patients with chronic low
back pain.[24] The compression ratio of the anterior and posterior parts of the IntraSPINE is
different; i.e., the anterior part is full of medical silica gel, while the posterior part
is hollow inside. Enlargement of the laminar space is mainly facilitated by the anterior
part of the IntraSPINE, which is closer to the ligamentum flavum. The posterior part of the
IntraSPINE mainly affects dynamic stability and is located in the interspinous space. A
small-sample study showed that the IntraSPINE was able to reduce the workload on adjacent
levels compared with interspinous spacers.[25] Sixty-seven patients were treated with the IntraSPINE in a 3-year follow-up study
performed by Darwono,[26] and the result indicated that the IntraSPINE was close to the axis of instantaneous
rotation of the spinal motion segment; that is, the IntraSPINE seemed to stabilize the
segmental instability, maintain the sagittal balance, and restore the physiologic movement
of the spinal motion segment. Moreover, the results of using the IntraSPINE for treatment of
degenerative disc disease at the L5–S1 segment were encouraging in a study by Caspar et al.[27] Guizzardi and Morichi[28] verified the efficacy of the IntraSPINE in stopping or reversing the progressive
cascade associated with disc degeneration. Another study corroborated that the IntraSPINE
was an excellent alternative treatment for patients with chronic low back pain due to
Baastrup’s disease.[29] According to the designer’s original intentions, the combination of the IntraSPINE
and lumbar spinal fusion is feasible for the treatment of degenerative lumbar disease.[11] However, this has not been supported by related clinical reports.In our case, protrusion of the intervertebral discs was found at the L2–3, L4–5, and L5–S1
levels. However, the width of the lumbar vertebral canal at the L3–4 level was acceptable;
that is, decompression of the L3–4 segment was unnecessary. If we had performed lumbar
spinal fusion of the L2–S1 segments, the patient would have undergone massive trauma,
excessive bleeding, and extensive posterior column destruction of the spine. The risk of ASD
would also have been increased. We considered the topping-off technique as another
alternative procedure that has been shown to be conducive to alleviating ASD.[30] However, the patient’s lumbar activity would have been limited if pedicle screws had
been inserted bilaterally at L3–S1 for internal fixation, and this might have seriously
affected her quality of life and increased the economic cost of surgery. Additionally, as
previously described, L3–S1 fusion might have increased the risk of ASD and postoperative
complications, potentially necessitating a second surgery.By the 14-month postoperative follow-up, the patient’s back pain and neurogenic
claudication symptoms had wholly disappeared, and the hypesthesia of both lower limbs had
become relieved to some degree. The location of the IntraSPINE at the L2–3 segment did not
move, the PDH at the L2–3 level recovered, and the local vertebral instability at the L2–3
level was resolved based on the postoperative and follow-up imaging examinations. That is,
the results of our attempt are encouraging. However, these results should be confirmed by
studies with larger cohorts and more extended postoperative follow-up periods.
Limitations
This case report describes an attempt to verify the feasibility of the combination of the
IntraSPINE and PLIF technique in treating SLDD. Although the outcome of this case is
encouraging, a randomized controlled trial is necessary.
Conclusion
The IntraSPINE combined with PLIF can be a feasible procedure for the treatment of SLDD.
Combination with lumbar spinal fusion may be one indication for the IntraSPINE. The
IntraSPINE device can maintain the stability of the lumbar spine and preserve the motion of
the spine to prevent the occurrence of ASD with minimal trauma and bleeding.
Authors: Fengyu Zheng; Frank P Cammisa; Harvinder S Sandhu; Federico P Girardi; Safdar N Khan Journal: Spine (Phila Pa 1976) Date: 2002-04-15 Impact factor: 3.468