Dataset Information

Efficiency of a novel vertebral body augmentation system (Tektona™) in non-osteoporotic spinal fractures.

ABSTRACT:

Background

The restauration of the local kyphosis is crucial to thoracolumbar fractures outcomes. Recently, the Tektona™ (Spine Art) system, constituted by a flexible lamella for corporeal reduction has emerged as a promising solution for osteoporotic fractures. However, no study has yet focused on its results on traumatic fractures.

Methods

A retrospective longitudinal study on prospectively collected data was conducted on 53 patients that had a kyphoplasty by Tektona™, associated or not to percutaneous fixation. The data collected were clinical, surgical and scannographic (measurement of AVH, MVH and PVH (anterior/medium/posterior vertebral height), and RTA (regional traumatic angle) in°), preoperatively, post-operatively and at last follow-up.

Results

Fractures were mainly located at the upper lumbar spine and were AOSpine A3 type for 74%. The mean RTA was 12° in pre-operative, 4° in post-operative (p = 2e^- 9), and 8° at the last follow-up (p = 0,01). The mean correction of RTA for the fixation group was - 10 ± 6° versus - 7 ± 4° for the kyphobroplasty alone group (p = 0,006). The mean correction for fractures located at T10-T12 was - 9 ± 3°, - 9 ± 5° for L1, - 8 ± 3° for L2 and - 5 ± 3° for L3-L5 (p = 0,045).

Conclusions

The Tektona® system appears to be efficient for acute thoraco-lumbar fractures, comparable to other available systems, allowing a real intracorporeal reduction work. Its relevance, especially in the long term needs further investigation. The association of a percutaneous fixation allow to obtain a better correction of the RTA but did not seem to prevent the loss of correction at follow-up.

SUBMITTER: Marie-Hardy L

PROVIDER: S-EPMC9008971 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Efficiency of a novel vertebral body augmentation system (Tektona™) in non-osteoporotic spinal fractures.

Marie-Hardy Laura L Mohsinaly Yann Y Pietton Raphaël R Stencel-Allemand Marion M Khalifé Marc M Bonaccorsi Raphaël R Barut Nicolas N Pascal-Moussellard Hugues H

BMC musculoskeletal disorders 20220413 1

<h4>Background</h4>The restauration of the local kyphosis is crucial to thoracolumbar fractures outcomes. Recently, the Tektona™ (Spine Art) system, constituted by a flexible lamella for corporeal reduction has emerged as a promising solution for osteoporotic fractures. However, no study has yet focused on its results on traumatic fractures.<h4>Methods</h4>A retrospective longitudinal study on prospectively collected data was conducted on 53 patients that had a kyphoplasty by Tektona™, associate ...[more]

PMID: 35418060

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Project description:BackgroundMost patients with osteoporotic vertebral compression fracture (OVCF) obtain pain relief after vertebral augmentation, but some will experience residual back pain (RBP) after surgery. Although several risk factors of RBP have been reported, it is still difficult to estimate the risk of RBP preoperatively. Radiomics is helpful for disease diagnosis and outcome prediction by establishing complementary relationships between human-recognizable and computer-extracted features. However, musculoskeletal radiomics investigations are less frequently reported.ObjectiveThis study aims to establish a radiomics score (rad-score) based nomogram for the preoperative prediction of RBP in OVCF patients.MethodsThe training cohort of 731 OVCF patients was used for nomogram development, and the validation cohort was utilized for performance test. RBP was determined as the score of visual analogue scale ≥ 4 at both 3 and 30 days following surgery. After normalization, the RBP-related radiomics features were selected to create rad-scores. These rad-scores, along with the RBP predictors initially identified by univariate analyses, were included in the multivariate analysis to establish a nomogram for the assessment of the RBP risk in OVCF patients preoperatively.ResultsA total of 81 patients (11.2%) developed RBP postoperatively. We finally selected 8 radiomics features from 1316 features extracted from each segmented image to determine the rad-score. Multivariate analysis revealed that the rad-score plus bone mineral density, intravertebral cleft, and thoracolumbar fascia injury were independent factors of RBP. Our nomograms based on these factors demonstrated good discrimination, calibration, and clinical utility in both training and validation cohorts. Furthermore, it achieved better performance than the rad-score itself, as well as the nomogram only incorporating regular features.ConclusionWe developed and validated a nomogram incorporating the rad-score and regular features for preoperative prediction of the RBP risk in OVCF patients, which contributed to improved surgical outcomes and patient satisfaction.

Project description:ObjectiveAlthough there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to provide a systematic review of cost-effectiveness studies and policy-based willingness-to-pay (WTP) thresholds for different vertebral augmentation (VA) procedures, vertebroplasty (VP) and balloon kyphoplasty (BK), for osteoporotic vertebral fractures (OVFs).DesignA systematic review targeting cost-effectiveness studies of VA procedures for OVFs.Data sourcesSix bibliographic databases were searched from inception up to May 2021.Eligibility criteria for study selectionStudies were eligible if meeting all predefined criteria: (1) VP or BK intervention, (2) OVFs and (3) cost-effectiveness study. Articles not written in English, abstracts, editorials, reviews and those reporting only cost data were excluded.Data extraction and synthesisInformation was extracted on study characteristics, cost-effective estimates, summary decisions and payer WTP thresholds. Incremental cost-effective ratio (ICER) was the main outcome measure. Studies were summarised by a structured narrative synthesis organised by comparisons with conservative management (CM). Two independent reviewers assessed the quality (risk of bias) of the systematic review and cost-effectiveness studies by peer-reviewed checklists.ResultsWe identified 520 references through database searching and 501 were excluded as ineligible by titles and abstract. Ten reports were identified as eligible from 19 full-text reviews. ICER for VP versus CM evaluated as cost per quality-adjusted life-year (QALY) ranged from €22 685 (*US$33 395) in Netherlands to £-2240 (*US$-3273), a cost-saving in the UK. ICERs for BK versus CM ranged from £2706 (*US$3954) in UK to kr600 000 (*US$90 910) in Sweden. ICERs were within payer WTP thresholds for a QALY based on historical benchmarks.ConclusionsBoth VP and BK were judged cost-effective alternatives to CM for OVFs in economic studies and were within WTP thresholds in multiple healthcare settings.

Dataset Information

Efficiency of a novel vertebral body augmentation system (Tektona™) in non-osteoporotic spinal fractures.

Background

Methods

Results

Conclusions

Publications

Efficiency of a novel vertebral body augmentation system (Tektona™) in non-osteoporotic spinal fractures.

Similar Datasets

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