Trial reportNeurosurgery2019
Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial.
Trial report in Neurosurgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01871519 (A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Incidence and predictors of residual back pain after percutaneous vertebral augmentation in osteoporotic vertebral compression fracture: a systematic review and meta analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Pooled it
- A deep-learning model for identifying fresh vertebral compression fractures on digital radiography.European radiology · 2022Trial
- Clinical comparison between a percutaneous hydraulic pressure delivery system and balloon tamp system using high-viscosity cement for the treatment of osteoporotic vertebral compression fractures.Clinics (Sao Paulo, Brazil) · 2019Trial
- Incidence and risk factors of subsequent vertebral fracture following percutaneous vertebral augmentation in postmenopausal women.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026Article
- Ablation-First Balloon-Assisted Acetabuloplasty for Painful Acetabular Metastases: Clinical Outcomes and Mechanical Rationale.Current oncology (Toronto, Ont.) · 2026Article
- Health-related Quality of Life After Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures.Current osteoporosis reports · 2026Review
- Subsequent vertebral fracture after percutaneous vertebroplasty or kyphoplasty in postmenopausal women with osteoporotic vertebral compression fracture.Frontiers in endocrinology · 2026Article
- Refracture and Mortality Following Surgical Management of Osteoporotic Vertebral Fractures: A Systematic Review and Meta-Analysis with Patient-Level Survival Modeling.Journal of clinical medicine · 2025Review
- Can Percutaneous Kyphoplasty Be a New Solution for Vertebral Fractures in Patients With Diffuse Idiopathic Skeletal Hyperostosis? Retrospective Study.International journal of spine surgery · 2025Article
- CT-based vertebral three-dimensional Hounsfield unit can predict the new vertebral fracture after percutaneous vertebral augmentation in postmenopausal women: a retrospective study.Journal of orthopaedic surgery and research · 2025Article
- Efficacy and safety of vertebral augmentation techniques in patients with osteoporotic vertebral compression fractures: A single center, retrospective, observational study.Interventional pain medicine · 2025Article
- Predictors of Vertebroplasty Selection in Older Adults with Osteoporotic Vertebral Compression Fractures: A Real-World Cohort Study.Clinical interventions in aging · 2025Article
- Developing predictive models for residual back pain after percutaneous vertebral augmentation treatment for osteoporotic thoracolumbar compression fractures based on machine learning technique.Journal of orthopaedic surgery and research · 2024Article
- Vertebroplasty and kyphoplasty in the management of osteoporotic vertebral compression fractures in elderly individuals: evaluation of the health-related quality of life.European journal of translational myology · 2024Article
- Incidence and risk factors of adjacent vertebral fracture after percutaneous vertebroplasty or kyphoplasty in postmenopausal women: a retrospective study.Scientific reports · 2024Article
- [Vertebral fractures combined with prolonged activated partial prothrombin time: A case report].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2024Article
- Percutaneous kyphoplasty through unilateral puncture on the convex side for the treatment of painful osteoporotic vertebral compression fracture with scoliosis.BMC musculoskeletal disorders · 2024Article
- The Effect of Kyphoplasty on Opioid Use in Patients With Vertebral Compression Fractures.Cureus · 2024Article
- Lateral Lumbar Interbody Fusion within Three-level for Patients with Neurological Symptoms due to Vertebral Fragility Fractures in the Lumbar Spine.Neurologia medico-chirurgica · 2023Observational
- Advances in Osteoporosis Therapy: Focus on Osteoanabolic Agents, Secondary Fracture Prevention, and Perioperative Bone Health.Current osteoporosis reports · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOsteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care.
objectiveTo investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice.
methodsA total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints-Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)-were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519).
resultsAt the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment.
conclusionThis large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.