scholarly journals Comparison of Rigid and Soft-Brace Treatments for Acute Osteoporotic Vertebral Compression Fracture: A Prospective, Randomized, Multicenter Study

2019 ◽  
Vol 8 (2) ◽  
pp. 198 ◽  
Author(s):  
Tsuyoshi Kato ◽  
Hiroyuki Inose ◽  
Shoichi Ichimura ◽  
Yasuaki Tokuhashi ◽  
Hiroaki Nakamura ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Back Pain ◽  
Outcome Measures ◽  
Vertebral Body ◽  
Compression Fracture ◽  
Secondary Outcome ◽  
Vertebral Compression Fractures ◽  
Brace Treatment ◽  
Compression Fractures

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.

173 EVOLVE - Significant Improvements in Pain, Disability, Quality of Life and Overall Health with Use of Balloon Kyphoplasty for Vertebral Compression Fractures in Medicare-Eligible Patients Despite Minimal Improvements in Vertebral Body Height an

Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 244-245
Author(s):  
John Amburgy ◽  
Douglas Beall ◽  
Richard Easton ◽  
Douglas Linville ◽  
Sanjay Talati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vertebral Body ◽  
Body Height ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Vertebral Body Height ◽  
Compression Fractures ◽  
Time Points ◽  
Pain Disability

Abstract INTRODUCTION Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful. In the U.S., there are more than 1.5 million vertebral fractures annually and 40% of those over the age of 80 will experience this pathology, threatening quality of life and increasing morbidity and mortality. Kyphoplasty is a minimally invasive surgery to stabilize the fracture and recent EVOLVE analysis demonstrated minimal improvement in kypohotic angulation or vertebral body height, however, patients demonstrated significant improvements in pain, disability, quality of life and overall health. METHODS Prospective, multicenter 12-month clinical study of outcomes pertaining to activities of daily living, pain, quality of life, and safety parameters in a Medicare-eligible population treated with kyphoplasty for painful acute or subacute VCFs associated with osteoporosis or cancer. RESULTS >NRS back pain improved from 8.7 (scale 0–10) by 5.2, 5.4, 6.0, 6.2 and 6.3 points, at the 7-day, and the 1, 3, 6 and 12-month time points, respectively. ODI improved from 63.4 (scale 0–100) by 30.5, 35.3, 36.3 and 36.2 points, at the 1, 3, 6 and 12-month time points, respectively. The SF-36 PCS was 24.2 at baseline (scale 0–100) and improved 10.7, 12.4, 13.4 and 13.8 points, at 1, 3, 6 and 12 months. The EQ-5D was 0.383 points (scale 0–1) and improved 0.316, 0.351, 0.356 and 0.358 points, at 1, 3, 6 and 12 months. All measures were statistically significant with P < 0.001 at every time point. Despite these significant improvements in pain, disability, qulity of life and overall health, there were only modest, but significant improvements in kyphotic angulation (1.1° improvement) and vertebral body height (4% improvement). CONCLUSION This large, prospective, multicenter study trial demonstrates that utilization of kyphoplasty for vertebral compression fractures provides significant improvements in pain, disability, quality of life, and overall health despite modest improvements in kyphotic angulation and vertebral body height in Medicare-eligible patients.

Final Results of the First Randomized Trial Comparing Balloon Kyphoplasty (BKP) to Non-Surgical Management Among Cancer Patients with Vertebral Compression Fractures: Marked Improvement in Back Function, Quality of Life and Pain in the BKP Arm.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2873-2873 ◽  
Author(s):  
James R Berenson ◽  
Robert Pflugmacher ◽  
Peter Jarzem ◽  
Jeffrey A Zonder ◽  
John B Tillman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Back Pain ◽  
Pain Relief ◽  
Randomized Trial ◽  
Cancer Patients ◽  
Research Funding ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Compression Fractures

Abstract Abstract 2873 Poster Board II-849 Destructive vertebral lesions are a common source of morbidity for patients with cancer. Balloon kyphoplasty (BKP) is a minimally invasive surgical procedure for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability. We report the final results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of BKP. Twenty-two multinational sites enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with cancer and ' 3 painful VCFs were randomly assigned to BKP or nonsurgical management (NSM) and followed for 12 months. Patients were excluded with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site, or spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire (RMDQ), a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Following this assessment, cross-over to BKP was allowed in the NSM arm. Patients were randomized to BKP (N=70) or NSM (N=64). Five patients withdrew early from the study without significant baseline data; the 3 patients assigned to BKP did not undergo the procedure. Thus, 68 BKP and 61 control patients were evaluable. Mean patient age was 64 years, 58% were female, and tumor types included multiple myeloma (38%), cancers of the breast (22%), lung (8.5%), prostate (6.2%) and other sites (26%). At baseline, 35% of patients were currently on daily corticosteroids, 50% had received bisphosphonates within 12 months of study entry, 49% had received prior radiation (52 % to the spine), and 67% of patients were previously treated with chemo/hormonal therapies. VCFs were identified in a single (34%), two (26%) or three (40%) sites. Mean baseline RMDQ scores were similar between the groups; 17.6 and 18.2 points for BKP and NSM patients, respectively. However, at one month, there was an improvement for patients randomized to BKP of −8.3 points (95% CI −6.4 to −10.2) whereas those receiving NSM showed no significant change (0.1 points, 95% CI 1.0 to −0.8; p<0.0001). At one week, BKP-treated patients also showed significant improvement in their back pain (−3.8 points, 95%CI, −3.1 to −4.6) whereas those patients treated with NSM had no change (−0.3 points, 95%CI, 0.1 to −0.7; p<0.0001). Similar results for pain were obtained at one month (BKP: −3.9 [95%CI, −3.1 to −4.7]; NSM: −0.6 [95%CI, −0.1 to −1.1]; p<0.0001). The greater pain relief observed in the BKP group was accompanied by a greater reduction in the usage of any analgesics to control pain relief within one month (p=0.002). BKP patients also reported fewer days (compared to NSM) within two weeks where their activity was limited due to back pain (6.3 fewer days per 2 weeks; 95%CI, 5.8 to 6.8; p<0.0001) and greater improvements in quality of life as measured by the SF-36 physical component summary score (8.4 points higher; 95%CI, 7.7 to 9.1; p<0.0001). Thirty-eight of the 61 patients in the NSM group crossed over and underwent BKP with 21 (58%) occurring within 1 week of the 1-month visit. These cross-over patients were also assessed for safety and efficacy at 1 month following the procedure and through the study period. They showed similar benefits in regards to back disability, back pain relief, analgesic use, activity level, and quality of life as those originally assigned to BKP. Among all patients treated with BKP, these improvements were sustained throughout the 12-month study period. Adverse events were similar between the two groups. One serious adverse event in the form of an intra-operative non-Q-wave myocardial infarction resolved and was attributed to anesthesia. One patient with a cement leakage to the disc had an adjacent fracture occur 1 day after the index procedure; the local investigator judged this to be device-related. This randomized study demonstrates that cancer patients with VCFs treated with BKP have a superior outcome compared to NSM as measured by the primary endpoint, the RMDQ score. BKP also resulted in a marked reduction in back pain, improved quality of life and fewer days with limitation of daily activities; these outcomes were both clinically and statistically significant and these effects were maintained throughout the 12 month study period. This study supports the benefits of BKP in the management of cancer patients with VCFs. Disclosures: Berenson: Medtronic Spine LLC: Consultancy, Research Funding. Pflugmacher:Medtronic Spine LLC: Research Funding. Jarzem:Medtronic Spine LLC: Research Funding. Zonder:Medtronic Spine LLC: Research Funding. Tillman:Medtronic Spine LLC: Employment. Ashraf:Medtronic Spine LLC: Employment. Vrionis:Medtronic Spine LLC: Research Funding.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

EVALUATION OF SHORT AND LONG TERM BENEFITS/SIDE EFFECTS OF CEMENT AUGMENTATION IN PATIENTS WITH NON INFECTIVE PATHOLOGICAL OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES

2020 ◽  
pp. 44-48
Author(s):  
Abhay Singh ◽  
Rahul Gupta ◽  
Shachi Shachi
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Pain Relief ◽  
Vertebral Compression Fracture ◽  
Compression Fracture ◽  
Cement Augmentation ◽  
Vertebral Compression Fractures ◽  
Hybrid Technique

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.

scholarly journals Quality of Life in Patients with Osteoporotic Vertebral Compression Fractures

2017 ◽  
Vol 24 (3) ◽  
pp. 187 ◽  
Author(s):  
Ho Jin Jung ◽  
Ye-Soo Park ◽  
Hyoung-Yeon Seo ◽  
Jae-Chul Lee ◽  
Ki-Chan An ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vertebral Compression Fractures ◽  
Osteoporotic Vertebral Compression Fractures ◽  
Compression Fractures
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