Failure of the Wallis Interspinous Implant to Lower the Incidence of Recurrent Lumbar Disc Herniations in Patients Undergoing Primary Disc Excision

Floman, Yizhar; Millgram, Michael; Smorgick, Yossi; Rand, Nahshon; Ashkenazi, Ely

doi:10.1097/bsd.0b013e318030a81d

Cited by 61 publications

(36 citation statements)

References 14 publications

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“…Though all the postoperative ODI means never reached the level of the CG population, for the majority of patients moderate disability was estimated. Our mid-term results suggest of substantial improvement in 1-2 years of observation attributed to studies [17,37,45], however, coincide with those short-term ones [6,7,41].…”

Section: Discussionmentioning

confidence: 42%

Clinical outcomes of patients with lumbar disc herniation, selected for one-level open-discectomy and microdiscectomy

2010

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The aim of our study was twofold: firstly, to compare the preoperative and postoperative results at midterm follow-up periods along with the data of the control group. Secondly, to evaluate the effectiveness among opendiscectomy and microdiscectomy surgical groups. In the present study, we investigated a cohort of 100 patients with the lumbar disc herniation causing low back pain compared to 100 subjects of the control group with the non-specific low back pain by applying physical activity, pain scale, Short Form 36 General Health Questionnaire and additional postoperative records of patient's satisfaction and complications level, consumption of analgesics, and return to work status. The quantitative analysis of all questionnaires showed substantial differences in the preoperative and postoperative groups. The best results were achieved at the second year follow-up period. However, there were no statistically significant differences in both the examined surgical subgroups (p [ 0.05). In addition, we estimated from moderate to great statistical significance (p \ 0.01-0.05) among preoperative and overall postoperative results: PHC and MHC in the SF-36, Oswestry and VAS. The total increased satisfaction, reherniation rate and return to work frequency comprised 40, 9 and 64%, respectively. The analgesics were still indicated for 21% of the patients. The results of the present study suggest of sufficient decompression in both surgical groups, as the health-related quality of life parameters (Oswestry, VAS and SF-36) were defined as clinically improved. Regardless of persisted minor pain in both areas, it remained greater in the low back than in the leg, which should be held for beneficial to decompressive surgery.

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Section: Discussionmentioning

confidence: 42%

Clinical outcomes of patients with lumbar disc herniation, selected for one-level open-discectomy and microdiscectomy

2010

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“…4,7,10,19,32,45,47,49,51 In our study, the overall reoperation rate was 9.6%: We performed removal of the interspinous spacer and decompressive surgery in 24 patients, additional instrumented fusion with pedicle screws in 63 cases, removal of the interspinous spacer only in 8 cases, and insertion of a new interspinous implant in 12 cases. We removed the IPD with no further spinal fixation or decompression in older patients with multiple comorbidities in whom major spinal surgery could have been life threatening.…”

Section: Discussionmentioning

confidence: 99%

Failure rates and complications of interspinous process decompression devices: a European multicenter study

Gazzeri

Galarza

Neroni

et al. 2015

FOC

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OBJECT Spacers placed between the lumbar spinous processes represent a promising surgical treatment alternative for a variety of spinal pathologies. They provide an unloading distractive force to the stenotic motion segment, restoring foraminal height, and have the potential to relieve symptoms of degenerative disc disease. The authors performed a retrospective, multicenter nonrandomized study consisting of 1108 patients to evaluate implant survival and failure modes after the implantation of 8 different interspinous process devices (IPDs). METHODS The medical records of patients who had undergone placement of an IPD were retrospectively evaluated, and demographic information, diagnosis, and preoperative pain levels were recorded. Preoperative and postoperative clinical assessments in the patients were based on the visual analog scale. A minimum of 3 years after IPD placement, information on long-term outcomes was obtained from additional follow-up or from patient medical and radiological records. RESULTS One thousand one hundred eight patients affected by symptomatic 1- or 2-level segmental lumbar spine degenerative disease underwent placement of an IPD. The complication rate was 7.8%. There were 27 fractures of the spinous process and 23 dura mater tears with CSF leakage. The ultimate failure rate requiring additional surgery was 9.6%. The reasons for revision, which always involved removal of the original implant, were acute worsening of low-back pain or lack of improvement (45 cases), recurrence of symptoms after an initial good outcome (42 cases), and implant dislocation (20 cases). CONCLUSIONS The IPD is not a substitute for a more invasive 3-column fusion procedure in cases of major instability and spondylolisthesis. Overdistraction, poor bone density, and poor patient selection may all be factors in the development of complications. Preoperatively, careful attention should be paid to bone density, appropriate implant size, and optimal patient selection.

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“…Floman et al [6] used the Wallis device after primary disc excision in the hope of reducing recurrent disc herniation. In their non-randomized study, they found the implant to probably be incapable of reducing the incidence of recurrent herniation.…”

Section: Discussionmentioning

confidence: 99%

Effect of a novel interspinous implant on lumbar spinal range of motion

Gunzburg¹,

Szpalski

Callary

et al. 2009

Eur Spine J

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Interspinous devices have been introduced to provide a minimally invasive surgical alternative for patients with lumbar spinal stenosis or foraminal stenosis. Little is known however, of the effect of interspinous devices on intersegmental range of motion (ROM). The aim of this in vivo study was to investigate the effect of a novel minimally invasive interspinous implant, InSwing Ò , on sagittal plane ROM of the lumbar spine using an ovine model. Ten adolescent Merino lambs underwent a destabilization procedure at the L1-L2 level simulating a stenotic degenerative spondylolisthesis (as described in our earlier work; Spine 15: [571][572][573][574][575][576] 1990). All animals were placed in a side-lying posture and lateral radiographs were taken in full flexion and extension of the trunk in a standardized manner. Radiographs were repeated following the insertion of an 8-mm InSwing Ò interspinous device at L1-L2, and again with the implant secured by means of a tension band tightened to 1 N/m around the L1 and L2 spinous processes. ROM was assessed in each of the three conditions and compared using Cobb's method. A paired t-test compared ROM for each of the experimental conditions (P \ 0.05). After instrumentation with the InSwing Ò interspinous implant, the mean total sagittal ROM (from full extension to full flexion) was reduced by 16% from 6.3°to 5.3 ± 2.7°. The addition of the tension band resulted in a 43% reduction in total sagittal ROM to 3.6 ± 1.9°which approached significance. When looking at flexion only, the addition of the interspinous implant without the tension band did not significantly reduce lumbar flexion, however, a statistically significant 15% reduction in lumbar flexion was observed with the addition of the tension band (P = 0.01). To our knowledge, this is the first in vivo study radiographically showing the advantage of using an interspinous device to stabilize the (2009( ) 18:696-703 DOI 10.1007 spine in flexion. These results are important findings particularly for patients with clinical symptoms related to instable degenerative spondylolisthesis.Eur Spine J

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Failure of the Wallis Interspinous Implant to Lower the Incidence of Recurrent Lumbar Disc Herniations in Patients Undergoing Primary Disc Excision

Abstract: The current Wallis implant is probably incapable of reducing the incidence of recurrent herniations, but it still may be useful in patients with discogenic back pain due to early degenerative disc disease.

Cited by 61 publications

References 14 publications

Clinical outcomes of patients with lumbar disc herniation, selected for one-level open-discectomy and microdiscectomy

Clinical outcomes of patients with lumbar disc herniation, selected for one-level open-discectomy and microdiscectomy

Failure rates and complications of interspinous process decompression devices: a European multicenter study

Effect of a novel interspinous implant on lumbar spinal range of motion

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