Carlo Ambrogio Logroscino

Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: Single-level and bi-level

Study Design. Prospective, concurrently enrolled, multicenter trials of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) were conducted for the treatment of patients with single-level and two-level (bi-level) degenerative disc disease of the cervical spine. Objectives. The studies were designed to determine whether new functional intervertebral cervical disc prosthesis can provide relief from objective neurologic symptoms and signs, improve the patient’s ability to perform activities of daily living, decrease pain, and maintain stability and segmental motion. Summary of Background Data. The concept of accelerated degeneration of adjacent disc levels as a consequence of increased stress caused by interbody fusion of the cervical spine has been widely postulated. Therefore, reconstruction of a failed intervertebral disc with functional disc prosthesis should offer the same benefits as fusion while simultaneously providing motion and thereby protecting the adjacent level discs from the abnormal stresses associated with fusion. Methods. Patients with symptomatic cervical radiculopathy and/or myelopathy underwent implantation with the Bryan prosthesis after a standard anterior cervical discectomy. At scheduled follow-up periods, the effectiveness of the device was characterized by evaluating each patient’s pain, neurologic function, and radiographically measured range of motion at the implanted level. Results. Clinical success for both studies exceeded the study acceptance criteria of 85%. At 1-year follow-up, the flexion-extension range of motion per level averaged 7.9 ± 5.3 degrees in the single-level study and 7.4 ± 5.1 degrees in the bilevel study. No devices have been explanted. Conclusions. Discectomy and implantation of the device alleviates neurologic symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports maintenance of motion. The procedure is safe and the patients recover quickly. At least 5 years of follow-up will be needed to assess the long-term functionality of the prosthesis and protective influence on adjacent levels.

Preliminary clinical experience with the Bryan Cervical Disc Prosthesis.

OBJECTIVE The concept of accelerated degeneration of adjacent disc levels as a consequence of increased stress caused by interbody fusion of the cervical spine has been widely postulated. Therefore, reconstruction of a failed intervertebral disc with a functional disc prosthesis should offer the same benefits as fusion while simultaneously providing motion and thereby protecting the adjacent level discs from the abnormal stresses associated with fusion. This study was designed to determine whether a new, functional intervertebral cervical disc prosthesis can provide relief from objective neurological symptoms and signs, improve the patient’s ability to perform activities of daily living, decrease pain, and provide stability and normal range of motion. METHODS We conducted a prospective, concurrently enrolled, multicenter trial of the Bryan Cervical Disc Prosthesis (Spinal Dynamics Corp., Mercer Island, WA) for the treatment of patients with single-level degenerative disc disease of the cervical spine. Patients with symptomatic cervical radiculopathy and/or myelopathy underwent implantation with the Bryan prosthesis after a standard anterior cervical discectomy. At scheduled follow-up periods, the effectiveness of the device was characterized by evaluating each patient’s pain, neurological function, and range of motion at the implanted level. RESULTS Analysis included data regarding 60 patients at 6 months with 30 of those patients at 1 year. Clinical success at 6 months and 1 year after implantation was 86 and 90%, respectively, exceeding the study’s acceptance criteria of 85%. These results compare favorably with the short-term clinical outcomes associated with anterior cervical discectomy and fusion reported in the literature. At 1 year, there was no measurable subsidence of the devices (based on a measurement detection threshold of 2 mm). Evidence of anterior and/or posterior device migration was detected in one patient and suspected in a second patient. There was no evidence of spondylotic bridging at the implanted disc space. The measured range of motion in flexion-extension, as determined by an independent radiologist, ranged from 1 to 21 degrees (mean range of motion, 9 ± 5 degrees). No devices have been explanted or surgically revised. CONCLUSION Discectomy and implantation of the device alleviates neurological symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports normal range of motion. The procedure is safe and the patients recover quickly. Restrictive postoperative management is not necessary. However, only after long-term follow-up of at least 5 years will it become clear whether the device remains functional, thus confirming these early favorable results. In addition, the influence on adjacent motion segments can be assessed after at least 5 years of follow-up.

Natural history of untreated idiopathic scoliosis after skeletal maturity

A total of 187 random cases of untreated idiopathic scoliosis, seen from a minimum of 15 to a maximum of 47 years after the end of growth, were reviewed. All curves increased after skeletal maturity (average progression: 0.4° per year). Thoracic curves tend to progress more than lumbar, lumbar more than thoracolumbar, and thoracolumbar more than double major curves. Pain was present in 114 cases (61%) and appeared more frequently in women, after pregnancies, and with fatigue. Cardiopulmonary symptoms were present in 42 patients (22%), especially those with thoracic and thoracolumbar curves greater than 40°. Psychologic disturbances were found in 35 cases (19%), mostly female patients with thoracic curves greater than 40°. The cosmetic appearance of these patients at long-term follow-up was better compared with that at the end of growth, even though the curves progressed. Patients with decompensation of the trunk at the end of growth seemed to improve with time. In an unselected group of patients with severe curves a mortality rate of 17% was found, twice as much as in the Italian general population.

Clinical Significance of Heterotopic Ossification in Cervical Disc Replacement: A Prospective Multicenter Clinical Trial

OBJECTIVE:Heterotopic ossification (HO) is a well-known complication in joint replacements, but its occurrence and clinical effect on cervical artificial discs has not yet been studied. The purpose of this study was to investigate the incidence of HO in cervical disc replacement, to identify any associated risk factors for HO, and to examine the relationship of HO with clinical outcomes. METHODS:The patient data for this observational study were obtained from the original Bryan Disc Study by the European Consortium. Occurrence of HO was defined by the McAfee classification on the cervical lateral x-rays at 12 months after surgery. Secondary outcome measurements included Odoms criteria and the Medical Outcomes Study Short-Form 36-Item Health Survey. RESULTS:Sixteen (17.8%) of the 90 studied patients experienced HO, and 6 (6.7%) of these patients experienced Grade 3 and 4 HO. Ten patients’ (11%) artificial discs were shown to have movement of less than 2 degrees on flexion and extension cervical x-ray at 12 months, with 4 of these patients having HO of Grade 3 or 4. Male sex (&khgr;2 = 4.1; P = 0.0407) and older patients (P = 0.023; odds ratio = 1.10; 95% confidence interval = 1.01–1.19) were associated with development of HO. CONCLUSION:There is a strong association of the occurrence of HO with subsequent loss of movement of the implanted cervical artificial disc. We have found that sex and age are two possible risk factors in the development of HO after cervical disc replacement.

Histological analysis of the coracoacromial arch: correlation between age-related changes and rotator cuff tears

The purpose of this study was to analyze age-related changes in the coracoacromial arch and correlate these degenerative changes with rotator cuff tears. We obtained 80 shoulders from 40 cadavers. The mean age at death was 58.4 years. We performed a gross examination of the rotator cuff and the acromion and histological examination of the coracoacromial ligament. The statistical significance of any difference for each group considered was determined by Students t-test. The rotator cuff was normal in 66 specimens; there was an articular-side partial tear in 4 cases, a bursal-side partial tear in 6 cases, and a full-thickness tear in 4 cases. Age was correlated with increasing incidence and severity of cuff tears. We noted age-related degenerative changes in the coracoacromial ligament, degeneration of the acromial bone-ligament junction, and acromial spur formation. Anterior acromial spur was not related to the morphology of the acromion. We observed an increased incidence of bursal-side and complete cuff tears when the acromion was curved or beaked. Degenerative changes in the undersurface of the acromion were also present when the rotator cuff was normal. Bursal-side and complete cuff tears were associated with severe degenerative changes in the acromion in 100% of cases. Articular-side cuff tears were not related either to acromial morphology or degenerative changes in the coracoacromial arch. The association between cuff tears and acromial spur was more evident in the presence of a type III acromion. Our results would suggest that the incidence and severity of rotator cuff tears are correlated with aging and with the morphology of the acromion. Rotator cuff tears that involve the bursal side are often associated with changes in the coracoacromial ligament and the undersurface of the acromion. However, degenerative changes in the coracoacromial arch are always related to aging, also in the presence of a normal rotator cuff. Articular-side partial tears do not cause damage to the undersurface of the acromion.

Association between IL-6 and MMP-3 gene polymorphisms and adolescent idiopathic scoliosis : A case-control study

Study Design. Case-control study. Objective. As inflammation plays a key role in the etiology of intervertebral disc degeneration, we suggest a possible contribution of pro-inflammatory gene polymorphisms in the pathogenesis of adolescent idiopathic scoliosis (AIS). Summary of Background Data. The nucleus pulposus of scoliotic discs responds to exogenous stimuli by secreting interleukin-6 (IL-6) and other inflammatory cytokines. The association between matrix metalloproteinases (MMPs) and disc degeneration has been reported by several investigators. A human MMP-3 promoter 5A/6A gene polymorphism regulates MMP-3 genes expression, while the G/C polymorphism of the promoter region of IL-6 gene influences levels and functional activity of the IL-6 protein. Methods. We conducted a case-control study to investigate whether the 5A/6A polymorphism of the MMP-3 gene and the G/C polymorphism of the promoter region of IL-6 gene were associated with susceptibility to AIS. Results. The frequency of the 5A/5A genotype of MMP-3 gene polymorphism in patients with scoliosis was almost 3 times higher than in controls (30.2% vs. 11.2%, p 0.001), and the frequency of the G/G genotype of IL-6 gene polymorphism in patients with scoliosis was almost 2 times higher than in controls (52.8% vs. 26.2%, P < 0.001). 5A/5A genotype of MMP-3 gene polymorphism and G/G genotype of IL-6 gene polymorphism are independently associated with a higher risk of scoliosis (odds ratio, respectively, 3.34 and 10.54). Conclusion. This is the first study that has evaluated the possibility that gene variants of IL-6 and MMPs might be associated with scoliosis and suggests that MMP-3 and IL-6 promoter polymorphisms constitute important factors for the genetic predisposition to scoliosis.

Percutaneous acetabuloplasty for metastatic acetabular lesions

BackgroundOsteolytic metastases around the acetabulum are frequent in tumour patients, and may cause intense and drug-resistant pain of the hip. These lesions also cause structural weakening of the pelvis, limping, and poor quality of life. Percutaneous acetabuloplasty is a mini-invasive procedure for the management of metastatic lesions due to carcinoma of the acetabulum performed in patients who cannot tolerate major surgery, or in patients towards whom radiotherapy had already proved ineffective.MethodsWe report a retrospective study in 25 such patients (30 acetabuli) who were evaluated before and after percutaneous acetabuloplasty, with regard to pain, mobility of the hip joint, use of analgesics, by means of evaluation forms: Visual Analog Scale, Harris Hip Score, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC), Eastern Cooperative Oncology Group (ECOG). The results obtained were analysed using the χ2 Test and Fishers exact test. Significance was sent at P < 0.05.ResultsMarked clinical improvement was observed in all patients during the first six post-operative months, with gradual a worsening thereafter from deterioration of their general condition.Complete pain relief was achieved in 15 of our 25 (59%) of patients, and pain reduction was achieved in the remaining 10 (41%) patients. The mean duration of pain relief was 7.3 months. Pain recurred in three patients (12%) between 2 weeks to 3 months. No major complications occurred. There was transient local pain in most cases, and 2 cases of venous injection of cement without clinical consequences.ConclusionPercutaneous acetabuloplasty is effective in improving the quality of life of patients with osteolytic bone tumours, even though the improvement is observed during the first 6 months only. It can be an effective aid to chemo- and radiotherapy in the management of acetabular metastases.

Complications in lumbar spine surgery: A retrospective analysis

Background: Surgical treatment of adult lumbar spinal disorders is associated with a substantial risk of intraoperative and perioperative complications. There is no clearly defined medical literature on complication in lumbar spine surgery. Purpose of the study is to retrospectively evaluate intraoperative and perioperative complications who underwent various lumbar surgical procedures and to study the possible predisposing role of advanced age in increasing this rate. Materials and Methods: From 2007 to 2011 the number and type of complications were recorded and both univariate, (considering the patients’ age) and a multivariate statistical analysis was conducted in order to establish a possible predisposing role. 133 were lumbar disc hernia treated with microdiscetomy, 88 were lumbar stenosis, treated in 36 cases with only decompression, 52 with decompression and instrumentation with a maximum of 2 levels. 26 patients showed a lumbar fracture treated with percutaneous or open screw fixation. 12 showed a scoliotic or kyphotic deformity treated with decompression, fusion and osteotomies with a maximum of 7.3 levels of fusion (range 5-14). 70 were spondylolisthesis treated with 1 or more level of fusion. In 34 cases a fusion till S1 was performed. Results: Of the 338 patients who underwent surgery, 55 showed one or more complications. Type of surgical treatment (P = 0.004), open surgical approach (open P = 0.001) and operative time (P = 0.001) increased the relative risk (RR) of complication occurrence of 2.3, 3.8 and 5.1 respectively. Major complications are more often seen in complex surgical treatment for severe deformities, in revision surgery and in anterior approaches with an occurrence of 58.3%. Age greater than 65 years, despite an increased RR of perioperative complications (1.5), does not represent a predisposing risk factor to complications (P = 0.006). Conclusion: Surgical decision-making and exclusion of patients is not justified only by due to age. A systematic preoperative evaluation should always be performed in order to stratify risks and to guide decision-making for obtaining the best possible clinical results at lower risk, even for elderly patients.

Relevance of the cranioaxial angle in the occipitocervical stabilization using an original construct: a retrospective study on 50 patients.

We present a retrospective study on a series composed of 50 patients, treated between 1992 and 2006, affected by pathologies of the craniocervical junction. All the patients were treated using an innovative procedure based on a cranial claw made up of low profile hooks, conceived by one of the authors. Advantages of this technique are, to our point of view, a higher resistance to cranial hooks dislodgment, when compared with screw fixation instrumentation, especially in pathological conditions, such as rheumatoid arthritis that leads to a qualitative deterioration of the bone stock and to the reduction of the occipital wall thickness. Occipitoaxial alignment was assessed radiographically using the McGregor line. We observed an improvement in the subjective evaluation of pain in all treated patients with a 46% improvement from the initial values. Moreover, patient stabilized with an occipitoaxial angle included in the physiological range showed better results either for the survival of the instrumentation or the onset of junctional pathology. Patients have been followed up afterwards and evaluated by the visual analogue scale for the assessment of pain and by the Nurick scale for the cases associated with myelopathy. We believe that cranial anchorage with a hook claw allows for an instrumentation provided with high stability, particularly useful in revision surgery and major instabilities. The study of the occipitoaxial angles showed that the better results and the long-lasting stability of the implant are correlated to a fusion angle included in the physiological range.

Onset of a Charcot spinal arthropathy at a level lacking surgical arthrodesis in a paraplegic patient with traumatic cord injury

The study design included a case report of Charcot spinal arthropathy treated with posterior and anterior spinal instrumentation. The objective of the study was to report an unusual case of Charcot spinal arthropathy as a late complication of traumatic spinal cord injury in a patient previously treated with a long posterior thoraco-lumbar instrumentation and postero-lateral fusion. A 33-year-old man with T10–T11 complete paraplegia presented with focal low back pain, kyphotic deformity of the lumbar region with L2–L3 fracture–dislocation and hardware failure. Our treatment consisted of a circumferential arthrodesis performed with a combined anterior and posterior approach. Spinal stabilization was achieved and the patient was pain free and able to resume a sitting posture. This report suggests that the development of a Charcot spine arthropathy must always be considered as a late complication of a spinal cord injury. Moreover, we would emphasize the fundamental role of a strict clinical and radiological follow-up in order to detect an early Charcot spine complication.