I found this about the X-Stop Spacer....





Copyright Springer-Verlag 2007
High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis
Olaf J. Verhoof, Johannes L. Bron, Frits H. Wapstra, and Barend J. van RoyenDepartment of Orthopaedic Surgery, VU University Medical Center, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands
Barend J. van Royen, Phone: +31-20-4442355, Fax: +31-20-4442357, ; Email: BJ.vanRoyen@vumc.nl.
Corresponding author.
Received February 13, 2007; Revised July 6, 2007; Accepted August 17, 2007.
This article has been cited by other articles in PMC.
Other Sections
AbstractIntroductionPatients and methodsResultsDiscussionCompeting interestsReferencesAbstract
The X-Stop interspinous distraction device has shown to be an attractive alternative to conventional surgical procedures in the treatment of symptomatic degenerative lumbar spinal stenosis. However, the effectiveness of the X-Stop in symptomatic degenerative lumbar spinal stenosis caused by degenerative spondylolisthesis is not known. A cohort of 12 consecutive patients with symptomatic lumbar spinal stenosis caused by degenerative spondylolisthesis were treated with the X-Stop interspinous distraction device. All patients had low back pain, neurogenic claudication and radiculopathy. Pre-operative radiographs revealed an average slip of 19.6%. MRI of the lumbosacral spine showed a severe stenosis. In ten patients, the X-Stop was placed at the L45 level, whereas two patients were treated at both, L34 and L45 level. The mean follow-up was 30.3 months. In eight patients a complete relief of symptoms was observed post-operatively, whereas the remaining 4 patients experienced no relief of symptoms. Recurrence of pain, neurogenic claudication, and worsening of neurological symptoms was observed in three patients within 24 months. Post-operative radiographs and MRI did not show any changes in the percentage of slip or spinal dimensions. Finally, secondary surgical treatment by decompression with posterolateral fusion was performed in seven patients (58%) within 24 months. In conclusion, the X-Stop interspinous distraction device showed an extremely high failure rate, defined as surgical re-intervention, after short term follow-up in patients with spinal stenosis caused by degenerative spondylolisthesis. We do not recommend the X-Stop for the treatment of spinal stenosis complicating degenerative spondylolisthesis.Keywords: Lumbar spinal stenosis, X-Stop, Degenerative spondylolisthesis Other Sections
AbstractIntroductionPatients and methodsResultsDiscussionCompeting interestsReferencesIntroduction
Lumbar spinal stenosis complicating degenerative spondylolisthesis is a common cause for low back pain, neurogenic claudication, and radiculopathy in the elderly population. The majority of the patients will respond well to non-operative treatment modalities. However, in patients that fail to respond to conservative treatment, surgical decompression with or without a posterolateral fusion and instrumentation, may be considered [3, 12]. Unfortunately, these procedures have variable long-term outcomes and are frequently followed by complications, especially in the elderly patients with high co-morbility [2, 10]. Therefore, alternative therapies are being developed, of which the interspinous distraction device is rapidly gaining popularity [4, 9]. Of such, the X-Stop (X-Stop, St. Francis Medical Technologies, Inc, Alameda, CA) has been introduced as a minimal invasive surgical procedure to treat symptomatic degenerative lumbar spinal stenosis [4, 9]. Initial results of the treatment of degenerative lumbar spinal stenosis with the X-Stop are promising [8, 13, 14]. Recently, encouraging results have been reported for the treatment of patients with symptomatic lumbar spinal stenosis caused by degenerative spondylolisthesis [1]. However, we observed an alarmingly high failure rate, defined as surgical re-intervention, in a cohort of patients treated with the X-Stop for symptomatic lumbar spinal stenosis caused by degenerative spondylolisthesis. This prompted us to perform a retrospective chart review, and analysis of the radiographs. Other Sections
AbstractIntroductionPatients and methodsResultsDiscussionCompeting interestsReferencesPatients and methods
We retrospectively reviewed 12 consecutive patients with symptomatic lumbar spinal stenosis caused by degenerative spondylolisthesis treated with the X-Stop interspinous distraction device. The patients were treated between January 2003 and May 2005. There were 9 female and 3 male patients with a mean age at surgery of 67.5 years (5083). All patients complained of progressive low back pain throughout the day with neurogenic claudication, radiculopathy and a diminished walking distance. In all patients, neurological examination was judged normal or nonspecific. Anteroposterior, lateral and flexion/extension plain radiographs, and magnetic resonance imaging (MRI) were performed in all cases. The percentage of degenerative slip was measured on the lateral radiograph and measured according to the method described by Anderson et al. [1]. The anteroposterior dural sac diameter in the axial and sagittal plane T2 sequence was measured on the MRI. A standardized walking and cycling test [6] was performed at the department of physical therapy. A limited walking distance less than 1 km (0.62 miles) independent of the time needed, was considered positive. After walking the patient had to sit and the pre-walking pain must be reduced in less than 5 min. Cycling should be unlimited without complaints. Initial treatment consisted on patient education, medications to control pain, and exercise and physical treatments to regain or maintain activities of daily living. Surgical treatment with the X-Stop was considered in patients not improving with conservative care for more than 6 months.All operations were performed under general anesthesia. The patients were placed in prone position on a Wilson spinal surgery frame (Orthopaedic Systems, Inc., Union City, CA) with the lumbar spine in maximum flexion. Prophylactic antibiotics, cefazolin (cefalosporin, Kefzol) 1,000 mg IV, were administered at the induction of anesthesia, and as a second and third dose 8 and 16 h post-operatively, respectively. After radiographic identification of the surgical level, a mid-sagittal incision of approximately 4 cm is made over the spinous processes. The musculature was elevated to the level of laminae and facets. The supraspinal ligament is kept intact. To pierce the interspinous ligament, a curved dilator is inserted in the anterior margin of the interspinous space. Subsequently, a sizing distractor is inserted to determine the appropriate implant size. The X-Stop is inserted into the interspinous space as close to the posterior aspect of the lamina as possible. An adjustable wing is attached to the implant and secured along the midline. Patients were mobilized immediately once they had recovered from the anesthetic effects. They were discharged from hospital within 48 h.Clinical follow-up took place at 6 and 12 weeks and at 12 and 24 months. All patients underwent a clinical and radiographic examination of the lumbar spine in standing position at each follow-up visit. The mean follow-up was 30.3 months (1341). In patients with persistent or recurrence low back pain with neurogenic claudication and radiculopathy, a second MRI was made. The endpoint was secondary surgical intervention of the lumbar spine. Statistical analysis, comparing the pre- en post-operative MRI dimensions, was performed using Students t-test. Other Sections
AbstractIntroductionPatients and methodsResultsDiscussionCompeting interestsReferencesResults
The pre-operative percentage of degenerative spondylolisthesis was less than 30% in all patients, with an average slip of 19.6% 6.20 (9.629.7). In 9 out of the 12 patients there was a slip of less than 25% (grade 1) degenerative spondylolisthesis. Bending radiographs revealed mobility at the level of the spondylolisthesis in all patients. MRI showed nerve root compression and impingement of the thecal sac. The mean anteroposterior axial cross-sectional diameter was 7.33 mm (5.7111.19) and the mean anteroposterior sagittal cross-sectional diameter was 7.32 mm (5.408.49).The operations were performed at L45 in ten of the patients and at both L34 and L45 in two patients. A 14-mm diameter X-Stop was implanted in nine levels. In the remaining levels, a 12-mm implant was used three times, and 16 and 10-mm implants both once. No peri-operative complications were observed. Post-operative plain radiographs showed a correct position of the implants in all patients. No fractures of the spinous processes were observed. The post-operative percentage of spondylolisthesis, measured on plain radiographs post-operatively and at final follow-up, remained unchanged in all patients.Direct post-operatively, 8 out of 12 patient reported a significant improvement of pain, neurogenic claudication, and radiculopathy. However, four patients did not experience any relief of symptoms following surgery and no improvement at follow-up. At 12 weeks follow up, two patients, that initially had experienced a relief of symptoms suffered from a recurrence of pain, neurogenic claudication, and radiculopathy. In addition, a third patient experienced a recurrence of symptoms at 24 months follow-up.All patients with persistent or recurrent symptoms had a post-operative MRI. No statistically significant (P > 0.05) difference of spinal stenosis was seen at the effected levels in comparison to the pre-operative values. The mean post-operative anteroposterior axial cross sectional diameter was 6.80 mm (5.247.65) and the mean sagittal cross sectional diameter was 6.91 mm (5.127.70) (Fig. 1, ,2,2, ,3).3). The pre-operative axial and sagittal cross sectional diameter in these seven patients (7 levels) was not significantly different (P > 0.05) from that of the five patients (7 levels) without persistent or recurrent symptoms. Finally, the seven patients with persistent or recurrent symptoms underwent surgical re-intervention. The mean degenerative spondylolisthesis of these seven patients was 17.8% 6.9. Six of these patients had a pre-operative degenerative spondylolisthesis of less than 25%. One patient had a 27.6% degenerative spondylolisthesis. The X-Stop was removed and a decompression and posterolateral fusion with instrumentation was performed.
Fig. 1
a Pre-operative lateral plain radiograph. b Post-operative lateral plain radiograph. X-Stop positioned at the level L45


Fig. 2
Pre-operative T2-weighted a transversal and b sagittal MR Image showing lumbar spinal stenosis due to discopathy, facet arthritis, ligamentum flavum hypertrophy and anterolisthesis


Fig. 3
Post-operative T2-weighted a transversal and b sagittal MR Image. No change in canal cross-sectional area and mid-sagittal diameter visible after insertion of the X-Stop at level L45

Other Sections
AbstractIntroductionPatients and methodsResultsDiscussionCompeting interestsReferencesDiscussion
The X-Stop interspinous distraction device has shown to be an attractive alternative to conventional surgical procedures in the treatment of symptomatic degenerative lumbar spinal stenosis [4, 9]. It may be questioned, however, if the X-stop will be effective in patients with lumbar spinal stenosis caused by degenerative spondylolisthesis also. To our best knowledge, there is only one study that investigated the clinical effects of the X-Stop in patients with lumbar spinal stenosis caused by degenerative spondylolisthesis [1]. In this study, 42 patients were treated with the X-Stop and compared to 33 patients with non-operative treatment. The indication for treatment was a percentage of slip of less than 25%. An overall clinical success rate of 63.4% was reported in the X-Stop treated patients compared to 12.9% in the non-operative treated patients after 2 year follow-up. Secondary surgery was required in 5 (11.9%) of the patients in the X-Stop group compared to 4 (12.1%) in the control group.Unfortunately, we experienced an extremely high failure rate, defined as surgical re-intervention, in a cohort of patients with lumbar spinal stenosis caused by degenerative spondylolisthesis treated with the X-Stop interspinous distraction device. In our cohort, the average percentage of slip was less than 25%, though in 3 patients the percentage of slip was between 25 and 30%. Surgical re-intervention was required in 7 (58%) patients within 24 months. Of these, only 1 patient had a slip of more than 25% (27.6%). There was no relation between the severity of the slip and the failures in our cohort. Our indication for re-intervention included recurrence or persistent and unremitting low back pain and persistent or progressive neurogenic claudication with radiculopathy. Both clinical and radiological findings were considered together for diagnosing failure of treatment. Unfortunately, we did not enclose pre- and post-operative outcome measurements. However, since the surgical goal of the X-Stop include pain reduction, improvement of neurological symptoms, and improvement of quality of live, re-intervention was considered as the endpoint for failure.In diagnosing spinal stenosis, thecal sac impingement and nerve root compression are seen on MRI. We observed no improvement of the axial and sagittal diameter of the central canal on the MRI after insertion of the X-Stop. In addition, no relation was found between the severity of the pre-operative spinal stenosis measured on MRI and an eventual secondary surgical intervention. Recently, in a study using positional MRI pre- and post-operatively following insertion of the X-Stop, improvement of the cross sectional area of the dural sack has been observed in 12 patients with symptomatic spinal stenosis [11]. This study, however, did not include patients with spinal stenosis caused by degenerative spondylolisthesis. Unfortunately, we do not have the opportunity to use the positional MRI. It may be hypothesized that the spinal stenosis will be more severe in a standing positional MRI, as a result of the instability in degenerative spondylolisthesis. A limitation of the present study is the lack of objective standards of measurement spinal stenosis on MRI. Nevertheless, all patients in our study showed pre-operative a severe thecal sack impingement at the level of degenerative spondylolisthesis. In addition, the spondylolisthesis, as measured on the lateral standing radiographs, did not show progression or improvement after surgery.From a biomechanical point of view, it may be questioned if the X-Stop interspinous distraction device provides any stabilizing effect on the affected motion segment and will increase the spinal canal in degenerative spondylolisthesis. It has been shown that the facet joints in patients with degenerative spondylolisthesis demonstrate an increased sagittal orientation [5, 7]. When the facet joints are orientated in a more sagittal plain, the resistance to shear forces is decreased. Obviously, the more sagittal orientation of the L4L5 segment combined with an interspinous distraction device may result in a progressive forward slip of the superior vertebra, and a progressive narrowing of the spinal canal and lateral recesses. Thus, the presence of a degenerative spondylolisthesis in patients with lumbar spinal stenosis may be considered as a contra indication for the X-Stop.In conclusion, the X-Stop interspinous distraction device showed an extremely high failure rate, defined as surgical re-intervention, after short term follow-up in patients with spinal stenosis caused by degenerative spondylolisthesis. We do not recommend the X-Stop for the treatment of lumbar spinal stenosis with degenerative spondylolisthesis, and we consider a degenerative spondylolisthesis a contra-indication for the X-Stop interspinous distraction device.Competing interests
No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. Other Sections
AbstractIntroductionPatients and methodsResultsDiscussionCompeting interestsReferencesReferences
1. Anderson PA, Tribus CB, Kitchel SH (2006) Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis. J Neurosurg Spine 4:463471 [PubMed]
2. Atlas SJ, Delitto A (2006) Spinal stenosis: surgical versus nonsurgical treatment. Clin Orthop Relat Res 443:198207 [PubMed]
3. Bassewitz H, Herkowitz H (2001) Lumbar stenosis with spondylolisthesis: current concepts of surgical treatment. Clin Orthop Relat Res 384:5460 [PubMed]
4. Christie SD, Song JK, Fessler RG (2005) Dynamic interspinous process technology. Spine 30:S73S78 [PubMed]
5. Cinotti G, Postacchini F, Fassari F, Urso S (1997) Predisposing factors in degenerative spondylolisthesis. A radiographic and CT study. Int Orthop 21:337342 [PubMed]
6. Dong G, Porter RW (1989) Walking and cycling tests in neurogenic and intermittent claudication. Spine 14:965969 [PubMed]
7. Grobler LJ, Robertson PA, Novotny JE, Pope MH (1993) Etiology of spondylolisthesis. Assessment of the role played by lumbar facet joint morphology. Spine 18:8091 [PubMed]
8. Kondrashov DG, Hannibal M, Hsu KY, Zucherman JF (2006) Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech 19:323327 [PubMed]
9. Richards JC, Majumdar S, Lindsey DP, Beaupre GS, Yerby SA (2005) The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication. Spine 30:744749 [PubMed]
10. Sengupta DK, Herkowitz HN (2003) Lumbar spinal stenosis. Treatment strategies and indications for surgery. Orthop Clin North Am 34:281295 [PubMed]
11. Siddiqui M, Nicol M, Karadimas E, Smith F, Wardlaw D (2005) The positional magnetic resonance imaging changes in the lumbar spine following insertion of a novel interspinous process distraction device. Spine 30:26772682 [PubMed]
12. Vibert BT, Sliva CD, Herkowitz HN (2006) Treatment of instability and spondylolisthesis: surgical versus nonsurgical treatment. Clin Orthop Relat Res 443:222227 [PubMed]
13. Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ et al (2004) A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J 13:2231 [PubMed]
14. Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ et al (2005) A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine 30:13511358 [PubMed]

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Articles from European Spine Journal are provided here courtesy of
Springer-Verlag PubMed articles by these authorsVerhoof, O. Bron, J. Wapstra, F. van Royen, B. PubMed related articles
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ReviewLumbar stenosis with spondylolisthesis: current concepts of surgical treatment.Clin Orthop Relat Res. 2001 Mar; (384):54-60.

[Clin Orthop Relat Res. 2001]ReviewTreatment of instability and spondylolisthesis: surgical versus nonsurgical treatment.Clin Orthop Relat Res. 2006 Feb; 443():222-7.

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[Clin Orthop Relat Res. 2006]ReviewLumbar spinal stenosis. Treatment strategies and indications for surgery.Orthop Clin North Am. 2003 Apr; 34(2):281-95.

[Orthop Clin North Am. 2003]ReviewDynamic interspinous process technology.Spine (Phila Pa 1976). 2005 Aug 15; 30(16 Suppl):S73-8.

[Spine (Phila Pa 1976). 2005]See more articles cited in this paragraphTreatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis.J Neurosurg Spine. 2006 Jun; 4(6):463-71.

[J Neurosurg Spine. 2006]Walking and cycling tests in neurogenic and intermittent claudication.Spine (Phila Pa 1976). 1989 Sep; 14(9):965-9.

[Spine (Phila Pa 1976). 1989]See more articles cited in this paragraphReviewDynamic interspinous process technology.Spine (Phila Pa 1976). 2005 Aug 15; 30(16 Suppl):S73-8.

[Spine (Phila Pa 1976). 2005]The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication.Spine (Phila Pa 1976). 2005 Apr 1; 30(7):744-9.

[Spine (Phila Pa 1976). 2005]Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis.J Neurosurg Spine. 2006 Jun; 4(6):463-71.

[J Neurosurg Spine. 2006]See more articles cited in this paragraphThe positional magnetic resonance imaging changes in the lumbar spine following insertion of a novel interspinous process distraction device.Spine (Phila Pa 1976). 2005 Dec 1; 30(23):2677-82.

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[Int Orthop. 1997]Etiology of spondylolisthesis. Assessment of the role played by lumbar facet joint morphology.Spine (Phila Pa 1976). 1993 Jan; 18(1):80-91.

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BTW, sorry for that long post, but basically the X-Stop has not been proven to work. The Balloon Kyphoplasty is basically recommended for spinal fractures, not just for any other spinal issue. So if you have a fracture in your spine the balloon will be good for you, if you don't, don't go there!
Do a lot more research on both procedures before saying yes to either one of them. Take care,

No fracture. Thanks.
brenda

Actually, I would have to respectfully disagree with Tipper1207. I have been researching X-stop for a year and its positive results are FAR above any other treatment for spinal stenosis. As long as the patient realizes this cannot "repair" disk degeneration but can, very effectively, relieve the pressure on the nerves that run down the buttocks and legs...the condition called spinal stenosis. Understanding this, most of the folks I have talked with are VERY happy with the results. Many, if not most, report a cessation of the butt and leg pain even as they get off the recovery table. At this time, most of the X-stop spacers are made of titanium but newer ones are coming on the marked made of polymers which are transparent to x-rays. I am scheduled for the procedure on Thursday and I promise you that I would NEVER put myself on the table without a fighting chance of success. It will be done under local anesthetic and I should be on my way a couple hours after the procedure with, naturally, orders not to bend, lift or twist for two months.

Oh yeah, I forgot, if it doesn't work properly or for some reason causes problems (very small likelihood from what I have read) the process can be easily reversed.

Orion,
I didn't write the article, the article was something that I found in a medical journal, so you are not disagreeing with me, you are disagreeing with the Doctor's and researchers that wrote the article. On that note I can tell you that a good friend of mine had the X-Stop in the UK and about 8 months later it had to be removed. For some reason she was left with a very, very unstable spine and she is now on a wheel-chair. This girl is only 32......

I've had both of these surgeries. I had kyphoplasty (balloon sugery)after a car wreck where I crushed 2 vertebra. Never seemed to help me. Then I had Zstop surgery a couple years after a laminectomy. The doctor and everyone in his office said that it had helped all of the patients who had had it....Not Me! Last summer a neurosurgeon wanted to do another surgery and put in pins and screws. I said no more back surgery. My doctor who did the first one - the kyphoplasty, said that a lot of times the disc above it or below it will go out, which probably happened, causing me to have the laminectomy, then he convinced me that after a neurosurgeon did that, that the Zstop would help. I am in so much pain in my back, I have degenerative disc disease, sciatica down both legs, and now an MRI showed that I have degeneration from S2 all the way up thru L6. I go to a Pain Management clinic where the doctor is a doctor of Anesthesia and she has done more for me with injections (series of 3 each time) for me than anyone.

Gosh, it sounds like any other surgery that leaves the spine unstable. I've had 2 hemilaminectomies/diskectomies, and after those, my spine became so unstable that I'm now disabled and inoperable.

Whether it's fusion or just plain ole' regular spinal surgery, the spine ends up unstable. Simple as that. It might not happen immediately, but it happens. Seems like you just can avoid it. Too bad.