Preliminary results of a soft novel lumbar intervertebral prothesis (DIAM) in the degenerative spinal pathology

Mariottini, Aldo; Pieri, Sergio; Giachi, S.; Carangelo, B; Zalaffi, Alessandro; Muzii, Vitaliano Francesco; Palma, Lucio

doi:10.1007/3-211-27458-8_28

Cited by 43 publications

(29 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Clinical reports have provided promising early data for a number of different interspinous implants including the X-stop [12,16], DIAM [7], and Wallis [9] for degenerative spinal conditions. Four-year results were obtained for the longest followed of these implants [5] and demonstrated an improved quality of life versus non-operative management [3].…”

Section: Discussionmentioning

confidence: 99%

“…Lumbar interspinous spacers, although not a new concept [14], is such an alternative for use in the degenerative conditions such as spinal canal and foraminal stenosis [5,12,16], segmental instability [1], and back pain [7,9]. Theoretically the implants are designed to unload the facet joints, and indirectly decompress the spinal canal or intervertebral foramen by providing distraction through the spinous processes and limiting extension at the implanted segment.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

An anatomic study of the interspinous space of the lumbosacral spine

et al. 2011

View full text Add to dashboard Cite

Purpose The purpose of this study is to quantify the interspinous anatomy at the L4/5 and L5/S1 levels. Methods One hundred reconstructed computer tomography scans of the lumbosacral spine were reviewed by two separate surgeons. Data were collected from the midline sagittal reconstructed image at the L4-5 and L5-S1 levels. Measurements obtained included the disc angle, anterior and posterior disc height, and maximum interspinous space in both the anterior-posterior and cephalad-caudal directions. The disc height and disc angle were correlated with the interspinous height. Results The mean age of the patients reviewed was 47 years (range: 16-91; standard deviation: 20). According to our data population, the average length of the interspinous space was larger at the L4-5 level (13 mm) than the L5-S1 level (9 mm). The interspinous height was similar between the two levels. A poor correlation existed between the disc height or disc angle and the interspinous height. There was no correlation between measurements and age. Conclusions The interspinous space available, as defined by computer tomography, at the L5/S1 level, is less able to accommodate current interspinous devices compared to the adjacent L4/5 level. The limiting factor is the length of the sacral part of the L5-S1 interspinous space.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An anatomic study of the interspinous space of the lumbosacral spine

et al. 2011

View full text Add to dashboard Cite

show abstract

“…Mariotti et al 50 had already described a positive result when studying the quality of life of a group of patients with lumbar stenosis that had surgery with interspinous systems, having however used the Dallas Pain Questionnaire. The following year, Hsu et al 51 confirmed that described by Mariotti, finding significant improvement in SF-36, studying patients with the same pathology operated with an identical technique.…”

Section: Discussionmentioning

confidence: 99%

Evolução psicossomática e clínica de pacientes com estenose do canal lombar operados com sistema interespinhoso

Consciência

2013

Coluna/Columna

View full text Add to dashboard Cite

Objective: The goal of this study was to evaluate the efficacy of interspinous spacers in degenerative lumbar disease and the evolution of patient's depression status and somatization preexisting symptoms. Methods: 20 patients with degenerative lumbar spinal stenosis were evaluated. Considering the different inclusion criteria, patients agreed to participate in the study by signing the written consent form. For clinical and psychosomatic assessment we used Euroqol Score (EQ-5D) for lumbar spine and lower limbs, Visual Analogue Scale (VAS); Oswestry Disability Index version 2.0 and Modified Somatic Perception Questionnaire (MSPQ); and Zung Self-Rating Depression Scale (ZDS). Statistical analysis was performed using Friedman and Wilcoxon tests, with significance level of 0.05. Results: There was an improvement in EQ-5D (p<0.001), VAS for lumbar spine and lower limbs (p<0.001), ODI (p<0.001), without significant changes in MSPQ (p=0.197). Conclusion: In patients with degenerative lumbar disease (Benzel grade 2, 3 and Pfirmann grade 3, 4) and stable in psychosomatic terms, the use of interspinous spacers proved effective clinical progression and improved the rate of depression related to the pre-existing pathology.Keywords: Spine; Quality of live; Depression; Orthopaedic fixation devices; Lumbar vertebrae/surgery. RESUMO Objetivo: Procuramos avaliar a eficácia terapêutica de estabilizadores interespinosos na doença degenerativa lombar, e a evolução do

show abstract

“…It is currently not FDA-approved; however, the US FDA-regulated clinical trial was already initiated in late 2006. Despite rates of postoperative patient satisfaction ranging from 87.5% to 97% at 12 to 17.7 months [5,10,19], complications such as spinous process fracture, infection, recurrent or residual disc protrusion, and newonset radiculopathy have been reported [5,10,19].…”

Section: Discussionmentioning

confidence: 99%

“…The interspinous spacers (ISPs) have been designed with the concept of distracting adjacent spinous processes, unloading the intervertebral disc, blocking spinal extension, and improving central canal and neuroforaminal stenosis. Although improvement in visual analog scale score and functional scores have been reported in many studies [5,10,19], complications such as Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.…”

Section: Introductionmentioning

confidence: 99%

Case Report: Cauda Equina Syndrome Associated With an Interspinous Device

Limthongkul

Yingsakmongkol

2012

Clinical Orthopaedics &Amp; Related Research

View full text Add to dashboard Cite

Background Although postoperative spinal epidural hematoma (SEH) is not uncommon, hematomas that require surgery are rare. Cauda equina syndrome (CES) may be associated with postoperative SEH. In these cases, early recognition and emergency decompression can prevent further damage and better neurologic recovery. Case Description A 41-year-old man underwent twolevel discectomy with insertion of an interspinous spacer at L3-4 and L4-5 because of low back pain and radiculopathy. Eight hours after the operation, the patient developed CES. MRI revealed SEH compressing posteriorly at the L3-4 level. On emergency decompression and hematoma evacuation, the interspinous spacer had obstructed the laminotomy site at L3-4 completely, blocking drainage to the drain. The patient experienced complete neurologic recovery by 2 months followup. Literature Review Many studies report risk factors for SEH. However, postoperative SEH can also be encountered in patients without these risks. One study reported a critical ratio (preoperative versus postoperative cross-sectional area) correlated with postoperative symptoms, especially in those with CES. The propensity to develop CES is likely dependent on a number of patient-specific factors. Clinical Relevance Surgeons should be aware that patients without risk factors may develop acute CES. Wider laminotomy (larger than half of the device size) may help to prevent this complication when one uses the compressible type of device, especially in patients with relatively small lamina.

show abstract

Preliminary results of a soft novel lumbar intervertebral prothesis (DIAM) in the degenerative spinal pathology

Cited by 43 publications

References 4 publications

An anatomic study of the interspinous space of the lumbosacral spine

An anatomic study of the interspinous space of the lumbosacral spine

Evolução psicossomática e clínica de pacientes com estenose do canal lombar operados com sistema interespinhoso

Case Report: Cauda Equina Syndrome Associated With an Interspinous Device

Contact Info

Product

Resources

About