Interspinous posterior devices: What is the real surgical indication?

Interspinous posterior device(IPD) is a term used to identify a relatively recent group of implants used to treat lumbar spinal degenerative disease. This kind of device is classified as part of the group of the dynamic stabilization systems of the spine. The concept of dynamic stabilization has been replaced by that of dynamic neutralization of hypermobility, with the intention of clarifying that the primary aim of this kind of system is not the preservation of the movement, but the dynamic neutralization of the segmental hypermobility which is at the root of the pathological condition. The indications for the implantation of an IPD are spinal stenosis and neurogenic claudication, assuming that its function is the enlargement of the neural foramen and the decompression of the roots forming the cauda equina in the central part of the vertebral canal. In the last 10 years, use of these implants has been very common but to date, no long-term clinical follow-up regarding clinical and radiological aspects are available. The high rate of reoperation, recurrence of symptoms and progression of degenerative changes is evident in the literature. If these devices are effectively a miracle cure for lumbar spinal stenosis, why do the utilization and implantation of IPD remain extremely controversial and should they be investigated further? Excluding theproblems related to the high cost of the device, the main problem remains the pathological substrate on which the device is explicit in its action: the degenerative pathology of the spine.

The effects of a new shape-memory alloy interspinous process device on the distribution of intervertebral disc pressures in vitro

This study was designed to measure the pressure distribution of the intervertebral disc under different degrees of distraction of the interspinous process, because of a suspicion that the degree of distraction of the spinous process may have a close relationship with the disc load share. Six human cadaver lumbar spine L2-L5 segments were loaded in flexion, neutral position, and extension. The L3-L4 disc load was measured at each position using pressure measuring films. Shape-memory interspinous process implants （SMID） with different spacer heights, ranging in size from 10 to 20 mm at 2 mm increments, were used. It was found that a SMID with a spacer height equal to the distance of the interspinous process in the neutral position can share the biomechanical disc load without a significant change of load in the anterior annulus. An interspinous process stabilizing device （IPD） would not be appropriate to use in those cases with serious spinal stenosis because the over-distraction of the interspinous process by the SMID would lead to overloading the anterior annulus which is a recognized cause of disc degeneration.

Interspinous Process Implants Causes Wear of the Spinous Processes in Patients Treated for Spinal Stenosis—An Experimental Biomechanical Study with Comparison to Clinical Cases

There are few biomechanical studies on Interspinous Process Implants (IPD);however none investigate the amount of wear on spinous processes. Therefore the objective of the present study was to investigate the effect of repetitive loading of the IPD Aperius on the spinous processes in a biomechanical porcine model. For comparison, three patients treated surgically with the same device have been followed for one to two years clinically and with image analyses (X-rays, MRI, CT-scans). Four lumbar spines from 6 months old porcine were divided into seven segments, which received IPD. The segments were exposed to 20,000 cyclical loads. Afterwards the deformation (wear) of the segments was registered. The wear of the spinous processes was measured in mm on a following CT-scan. Additionally, the wear of the ex-vivo was compared to that of the spinous processes investigated by CT-scans or X-ray in three patients treated surgically with the same interspinous implant. The mean maximal deformation of porcine specimens was 1.79 mm (SD 0.25) with the largest deformation occurring in the first quarter of the loading (<5000 cycles). The mean wear of the spinous processes after loading was 6.57 mm. A similar level of wear (mean 12.7 mm) of the spinous processes was detected in the patients. The Aperius IPD creates significant wear on the spinous processes in an experimental biomechanical study. Similar wear of the spinous processes is also present in patients treated with the same device post-operatively. How these findings influence the short and long term result of this implant device remains to be investigated in further biomechanical as well as clinical studies. For future development of this type of devices a proper selection of materials and design is essential to minimize wear effects on the spinous processes and thereby increases the possibilities for the devices to function as suggested.

Biomechanical comparison of interspinous distraction device and facet screw fixation system on the motion of lumbar spine： a finite element analysis

Background A large amount of biomechanical and clinical evidence from previous studies suggest the efficiency of the two different posterior lumber non-fusion methods,interspinous distraction device （ISDD） and facet screw fixation system （FSS）,but the biomechanical comparison of ISDD and FSS has not been thoroughly clarified.Methods In the current study,finite element methods were used to investigate the biomechanical comparison of ISDD and FSS.The range of motion （ROM）,intradiscal pressure （IDP） and the protective effects gained by maintaining disc heights were evaluated.Results The ROM was similar between the two non-fusion methods under static standing,flexion and lateral bending.The FSS appeared to be more effective in resisting extension.At the implanted level L3/4,FSS displayed better results for maintaining and increasing posterior disc heights.At the L4/5 level in extension and lateral bending,FSS was better than ISDD,with comparable results observed in other motions.Comparing the posterior and lateral disc heights,FSS appeared to be more effective than ISDD.FSS also had a minor effect on the inferior adjacent segment than ISDD.FSS was more effective in reducing IDP than ISDD in extension.Conclusion Through the finite element analysis study,it can be seen that FSS demonstrates more beneficial biomechanical outcomes than does ISDD,such as being more effective in resisting extension,maintaining and increasing lumbar disc heights and reducing the inferior adjacent IDP in extension.

Sonopelvimetry: An Innovative Method for Early Prediction of Obstructed Labour

Aim: To evaluate an innovative sonopelvimetry method for early prediction of obstructed labour. Methods: A prospective study was conducted in two centers.GPS-based sonopelvimetry, laborProTM?(Trig Medical Inc., Yoqneam Ilit, Israel) devise, was used prior to labour in nulliparous women at 39 - 42 weeks gestation remote from labor. Maternal pelvic parameters, including inter-iliac transverse diameter, obstetric conjugate and interspinous diameter were evaluated. Fetal parameters included head station, biparietal diameter and occipitofrontal diameter. Data on delivery and outcome were collected from the electronic files. Results: The innovative use of sonopelvimetry was applied to 154 consecutive women, none of the participants complained of discomfort or complications observed. The mean time of examination was 15 + 2 minutes. Mean time of examination to delivery interval was 4.8 days (range 0 - 16 days). Small interspinous diameter and high head station were the best predictors for obstructed labour. Analysis indicated 87% sensitivity and 61% specificity for birth weight fetal head station and ISD combined in predicting obstructed labour with an area under the curve of 0.77. Conclusions: Our results indicate that GPS-based?sonopelvimetry combined with fetal estimated weight is a valuable tool in the risk assessment of obstructed labour. Parameters obtained by sonopelvimetry combined with birth weight may be useful.

Elastic resistance of the spine:Why does motion preservation surgery almost fail?

Single metamere motility should not be interpreted merely as a movement on the 3 planes but also,and above all,as elastic resistance to dynamic stress on these 3 planes.In the light of this consideration,the aim of motion preservation is to neutralize excessive movements while preserving the physiological biomechanical properties of the metamere involved to interrupt the progression of degenerative processes and to prevent adjacent segment disease.Despite the fact that a myriad of devices have been developed with the purpose of achieving dynamic neutralization of the spine,there are now some doubts regarding the true efficacy of these devices.

Comparison of Topping-off and posterior lumbar interbody fusion surgery in lumbar degenerative disease： a retrospective study

Background Topping-off surgery is a newly-developed surgical technique which combines rigid fusion with an interspinous process device in the adjacent segment to prevent adjacent segment degeneration. There are few reports on Topping-off surgery and its rationality and indications remains highly controversial. Our study aims to investigate the short-term and mid-term clinical results of Topping-off surgery in preventing adjacent segment degeneration when mild or moderate adjacent segment degeneration existed before surgery. Methods The 25 cases that underwent L5-$1 posterior lumbar interbody fusion （PLIF） ＋ L4-L5 interspinous process surgeries between April 2008 and March 2010 formed Topping-off group. The 42 cases undergoing L5-$1 PLIF surgery formed PLIF group. Both groups matched in gender, age, body mass index and Pfirrmann grading （4 to 6）. The patients were evaluated with visual analogue scale （VAS） and Japanese orthopaedic association （JOA） scores before surgery and in the last follow-up. Modic changes of endplates were recorded. Results The follow-up averaged 24.8 and 23.7 months. No symptomatic or radiological adjacent segment degeneration was observed. There was no significant difference in intraoperative blood loss or postoperative drainage. VAS and lumbar JOA scores improved significantly in both groups （t=-12.1 and 13.5, P 〈0.05）. Neither anterior nor posterior disc height was significantly changed. Segmental lordosis of L4-L5 and total lordosis were all increased significantly （Topping-off group： t=-2.30 and -2.24, P 〈0.05; PLIF group： t=--2.76 and -1.83, P 〈0.01）. In the hyperextension and hyperflexion view, Topping-off group＇s range of motion （ROM） and olisthesis in the L4-L5 segment did not significantly change in flexion, but decreased in extension. In PLIF group, ROM （t=--7.82 and -4.90, P 〈0.01） and olisthesis （t=--15.67 and -18.58, P 〈0.01） both significantly increased in extension and flexion. Conclusions Compared with single segment PLIF surgery, Topping-off surgery can achieve similar symptomatic improvement in cases with pre-existing mild or moderate adjacent segment degeneration, restrict the adjacent segment＇s ROM in extension and prevent excessive olisthesis of adiacent seament in both extension and flexion