scholarly journals Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
David Noriega ◽  
Antonio Krüger ◽  
Francisco Ardura ◽  
Nils Hansen-Algenstaedt ◽  
Frank Hassel ◽  
...  

The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

2020 ◽  
pp. 44-48
Author(s):  
Abhay Singh ◽  
Rahul Gupta ◽  
Shachi Shachi

BACKGROUND: Vertebral compression fracture usually occurs in old age population with osteoporosis. Due to severity of pain, quality of life becomes very poor. During the study period 67 patients fullling the eligibility cri METHODS: teria underwent vertebroplasty/ kyphoplasty/ cement augmented screw xation/ hybrid procedures were included. Short term and long term benets /side effects were evaluated in all patients. Patients were evaluated on visual analogue score and modied ranking scale. RESULTS: Vertebroplasty was performed in 26(38.8%) whereas kyphoplasty, cement augmented screw xation and hybrid procedure were performed in 18(26.8%), 17(25.4%) and 6(9.0%) respectively. Signicant pain relief occurred in all patients which were evaluated by Visual Analogue Scale. Quality of life also improved which was evaluated with Modied Rankin Scale. In our study, complications which occurred were local cement leak, hematoma formation, infection in 8 (11.9%), 3(4.5%) and 2(3.0%) patients respectively. Use of biological cement has revolutionized CONCLUSION: the management of vertebral compression fracture. Both vertebroplasty and kyphoplasty procedures which are minimal invasive, almost cure the non infective pathological fractures with instant pain relief and very low procedure related morbidity. In cases requiring xation, cement augmentation signicantly improves the purchase of the screw and makes the construct more reliable. Hybrid technique helps to prevent extensive long level xation.


2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
David Noriega ◽  
Gianluca Maestretti ◽  
Christian Renaud ◽  
Natale Francaviglia ◽  
Mourad Ould-Slimane ◽  
...  

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°;p<0.001), remained at 12 months (-4.4±6.0°,p=0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.


2019 ◽  
Vol 8 (2) ◽  
pp. 198 ◽  
Author(s):  
Tsuyoshi Kato ◽  
Hiroyuki Inose ◽  
Shoichi Ichimura ◽  
Yasuaki Tokuhashi ◽  
Hiroaki Nakamura ◽  
...  

While bracing is the standard conservative treatment for acute osteoporotic compression fracture, the efficacy of different brace treatments has not been extensively studied. We aimed to clarify and compare the preventive effect of the different brace treatments on the deformity of the vertebral body and other clinical results in this patient cohort. This multicenter nationwide prospective randomized study included female patients aged 65–85 years with acute one-level osteoporotic compression fractures. We assigned patients within four weeks of injury to either a rigid-brace treatment or a soft-brace treatment. The main outcome measure was the anterior vertebral body compression percentage at 48 weeks. Secondary outcome measures included scores on the European Quality of Life-5 Dimensions (EQ-5D), visual analog scale (VAS) for lower back pain, and the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). A total of 141 patients were assigned to the rigid-brace group, whereas 143 patients were assigned to the soft-brace group. There were no statistically significant differences in the primary outcome and secondary outcome measures between groups. In conclusion, among patients with fresh vertebral compression fractures, the 12-week rigid-brace treatment did not result in a statistically greater prevention of spinal deformity, better quality of life, or lesser back pain than soft-brace.


Cancers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1596
Author(s):  
Marta Diaz-delCastillo ◽  
Rebecca E. Andrews ◽  
Aritri Mandal ◽  
Thomas L. Andersen ◽  
Andrew D. Chantry ◽  
...  

Multiple myeloma (MM) is a bone marrow neoplasia that causes bone pain in 70% patients. While preclinical models of MM have suggested that both nerve sprouting and nerve injury may be causative for the pain, there is a lack of clinical data. Thus, the primary aims of this clinical study are: (1) to provide a deep characterization of the subjective experience of pain and quality of life in MM patients; (2) to investigate disturbances in the bone innervation of MM patients. Secondary aims include exploring correlations between pain and serum inflammatory and bone turnover biomarkers. In a prospective, observational study (clinicaltrials.gov: NCT04273425), patients with suspected MM requiring a diagnostic iliac crest biopsy at Sheffield Teaching Hospital (UK) are invited to participate. Consenting patients answer seven standardized questionnaires assessing pain, quality of life and catastrophizing. Bone turnover biomarkers and inflammatory cytokines are measured in fasting serum samples, and bone innervation is evaluated in diagnostic biopsies. MM patients are invited to a follow-up upon completion of first line treatment. This will be the first deep characterization of pain in MM patients and its correlation with disturbances in bone innervation. Understanding how bone turnover and inflammation correlate to pain in MM is crucial to identify novel analgesic targets for this condition.


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