Publications by authors named "Francisco Ardura"

10 Publications

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Treatment of Thoracolumbar Type A3 Fractures Using a Percutaneous Intravertebral Expandable Titanium Implant: Long-term Follow-up Results of a Pilot Single Center Study.

Pain Physician 2021 Aug;24(5):E631-E638

Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Spain.

Background:   There are controversies about the optimal management of AO subtype A3 burst fractures. The most common surgical treatment consists of posterior fixation with pedicle screw and rod augmentation. Nevertheless, a loss of correction in height restoration and kyphotic reduction has been observed.

Objectives: The aim of this study was to assess long-term outcomes of a minimally invasive technique using a percutaneous intravertebral expandable titanium implant (PIETI).

Study Design: This prospective, single center, pilot study was carried out on a consecutive case series of 44 patients with acute (< 2 weeks) traumatic thoracolumbar fractures AO type A3. The average follow-up was 5.6 years.

Setting: A single center in Castilla y Leon, SpainMETHODS: Clinical outcomes (pain intensity on visual analog scale [VAS], Oswestry Disability Index [ODI], analgesic consumption) and radiographic outcomes (anterior/mid/posterior vertebral body height, vertebral area, local kyphosis angle, traumatic regional angulation) were analyzed before surgery, at one month after surgery, and at the end of the follow-up period.

Results: At one-month postsurgery, significant improvements in VAS score and ODI score were observed. PIETI achieved significant vertebral body height restoration with median height increases of 2.9 mm/4.3 mm/2.3 mm for anterior/middle/posterior parts, respectively. Significant correction of the local kyphotic angle and improvement of the traumatic regional angulation were accomplished. All these improvements were maintained throughout the follow-up period. The only complication reported was a case of cement leakage.

Limitations: In our opinion, the main limitation of the study is the small number of patients. However, the sample is superior to that shown in other papers.

Conclusions: This study showed that using a PIETI in the treatment of fractures type A3 is a safe and effective method that allows marked clinical improvement, as well as anatomical vertebral body restoration. Unlike with other treatments, results were maintained over time, allowing a better long-term clinical and functional improvement. The rate of cement leakage was lower than other reports.
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August 2021

Evaluation of the reduction, tightening and gripping performance of an innovative set screw technology for instrumented posterior lumbar fusion: A biomechanical study.

Orthop Traumatol Surg Res 2021 Mar 31:102918. Epub 2021 Mar 31.

Department of Orthopaedics and Traumatology, Academic Teaching Hospital Fulda, Pacelliallee 4, 36043 Fulda, Germany. Electronic address:

Background: Instrumented posterior lumbar fusion with top-loading pedicle screw systems (PSS) requires fully tightened set screws to achieve a secure fixation and symmetric load condition. This assumes a complete reduction of the rod by 90°, which is not always attainable in situ, especially under constraint. The objective of this work is to compare the mechanical performance of different innovative set screw technologies, which should improve the tightening process.

Hypothesis: The hypotheses of the study are that modifications to the screw and screwdriver unit can (1) improve the quality of set screw tightening and (2) increase the axial gripping capacity of the construct.

Materials And Methods: The four set screw technologies under investigation include a standard set screw with a flat surface (F-S; control group), a set screw with a convex surface (C-S) and a shaft tip method screwdriver used in combination with both flat (F-STM) and convex set screws (C-STM). The quality of set screw tightening is categorized as follows: failed=the rod is not completely reduced; reduced=the rod is successfully reduced but the set screw is not correctly fixed; good=remaining cases. An axial gripping capacity test is performed by a universal testing machine (Instron®) with a force capacity of 5kN.

Results: Regarding the quality of set screw tightening, comparisons between F-S vs. F-STM, F-S vs. C-STM and between C-S vs. C-STM show statistically significant differences (p<0.001). The axial gripping capacity test shows mean gripping forces of 1223N (STD 331) in the F-STM group and of 1724N (STD 168) in the C-STM group with statistically significant differences between both groups (p=0.003).

Discussion: Several biomechanical and clinical case studies have identified possible effects of misaligned rod-screw interfaces such as screw pull-out during rod reduction, screw loosening, screw or rod breakage, misalignment, adjacent segment degeneration and worsening of the clinical outcome. C-STM-technology thus supports controlled fixation in the sense of applying appropriate forces for correction or fixation during PSS assembly as well as friction-reduced final alignment and tightening with the aim to reduce implant loosening, hardware failure and reoperations, while respecting anatomical and biomechanical balance.
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http://dx.doi.org/10.1016/j.otsr.2021.102918DOI Listing
March 2021

Treatment of Degenerative Disc Disease With Allogeneic Mesenchymal Stem Cells: Long-term Follow-up Results.

Transplantation 2021 02;105(2):e25-e27

Instituto de Biología y Genética Molecular (IBGM), Universidad de Valladolid and Consejo Superior de Investigaciones Científicas (CSIC), Valladolid, Spain.

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http://dx.doi.org/10.1097/TP.0000000000003471DOI Listing
February 2021

Requirements for a Stable Long-Term Result in Surgical Reduction of Vertebral Fragility Fractures.

World Neurosurg 2017 Sep 31;105:137-144. Epub 2017 May 31.

Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, Valladolid, Spain. Electronic address:

Background: Osteoporotic vertebral fractures are one of the major health problems in the world. Minimally invasive surgical treatment has great advantages compared with conservative treatment in treating these fractures, because it eliminates pain and functional disability. The percutaneous intravertebral expandable titanium device SpineJack (Vexim SA, Balma, France) is beneficial compared with other kyphoplasty devices, showing results that are maintained over time and a reduction in complications. However, controversy exists about the minimum amount of cement that should be used to achieve long-term restoration and which is essential to minimize complications. We reviewed publications studying the maintenance of long-term restoration using this percutaneous expandable titanium device in cadavers. In this study, we show the first long-term work with patients treated with percutaneous expandable titanium device, describing precise indications concerning the minimum amount of cement that should be used.

Methods: Results were evaluated from a clinical study including 178 patient outcomes with long-term follow-up results performed by our team.

Results: The mean total quantity of cement injected was 4.4 mL (25% vertebral body filling). The leakage rate was 12.9%, and all of these occurrences were asymptomatic. The mean follow-up time was 77 months (60-96 months). All clinical scales improved significantly after the procedure. A recollapse of the treated vertebra was observed in 3 cases (1.6%), and the adjacent fracture rate was 2.2%.

Conclusions: From the results of our study and review of the literature, cement equivalent to 25% of the vertebral body filling volume, when combined with the titanium expandable device, seems to be sufficient to prevent recollapse in osteoporotic and type A.3 fractures.
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http://dx.doi.org/10.1016/j.wneu.2017.05.142DOI Listing
September 2017

Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial.

Transplantation 2017 08;101(8):1945-1951

1 Hospital Clínico Universitario de Valladolid, Orthopedic Surgery Department, Spine Unit, Valladolid, Spain. 2 Hospital Clínico Universitario de Valladolid, Radiology Department, Valladolid, Spain. 3 Citospin S.L., Parque Científico de la Universidad de Valladolid, Valladolid, Spain. 4 Hospital Universitario Virgen de la Arrixaca, Department of Hematology and Cell Therapy, Murcia, Spain. 5 Instituto de Biología y Genética Molecular (IBGM), Universidad de Valladolid and CSIC, Valladolid, Spain.

Background: Degenerative disc disease often causes severe low-back pain, a public health problem with huge economic and life quality impact. Chronic cases often require surgery, which may lead to biomechanical problems and accelerated degeneration of the adjacent segments. Autologous mesenchymal stromal cells (MSC) treatments have shown feasibility, safety and strong indications of clinical efficacy. We present here a randomized, controlled trial using allogeneic MSC, which are logistically more convenient than autologous cells.

Methods: We randomized 24 patients with chronic back pain diagnosed with lumbar disk degeneration and unresponsive to conservative treatments into 2 groups. The test group received allogeneic bone marrow MSCs by intradiscal injection of 25 × 10 cells per segment under local anesthesia. The control group received a sham infiltration of paravertebral musculature with the anesthetic. Clinical outcomes were followed up for 1 year and included evaluation of pain, disability, and quality of life. Disc quality was followed up by magnetic resonance imaging.

Results: Feasibility and safety were confirmed and indications of clinical efficacy were identified. MSC-treated patients displayed a quick and significant improvement in algofunctional indices versus the controls. This improvement seemed restricted to a group of responders that included 40% of the cohort. Degeneration, quantified by Pfirrmann grading, improved in the MSC-treated patients and worsened in the controls.

Conclusions: Allogeneic MSC therapy may be a valid alternative for the treatment of degenerative disc disease that is more logistically convenient than the autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves disc quality.
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http://dx.doi.org/10.1097/TP.0000000000001484DOI Listing
August 2017

Risk-benefit analysis of navigation techniques for vertebral transpedicular instrumentation: a prospective study.

Spine J 2017 01 5;17(1):70-75. Epub 2016 Aug 5.

Center for Orthopaedics and Trauma Surgery University Hospital Giessen and Marburg GmbH, Marburg, Germany.

Background Context: Pedicle screws in spinal surgery have allowed greater biomechanical stability and higher fusion rates. However, malposition is very common and may cause neurologic, vascular, and visceral injuries and compromise mechanical stability.

Purpose: The purpose of this study was to compare the malposition rate between intraoperative computed tomography (CT) scan assisted-navigation and free-hand fluoroscopy-guided techniques for placement of pedicle screw instrumentation.

Study Design/setting: This is a prospective, randomized, observational study.

Patient Sample: A total of 114 patients were included: 58 in the assisted surgery group and 56 in the free-hand fluoroscopy-guided surgery group.

Outcome Measures: Analysis of screw position was assessed using the Heary classification. Breach severity was defined according to the Gertzbein classification. Radiation doses were evaluated using thermoluminescent dosimeters, and estimates of effective and organ doses were made based on scan technical parameters.

Methods: Consecutive patients with degenerative disease, who underwent surgical procedures using the free-hand, or intraoperative navigation technique for placement of transpedicular instrumentation, were included in the study.

Results: Forty-four out of 625 implanted screws were malpositioned: 11 (3.6%) in the navigated surgery group and 33 (10.3%) in the free-hand group (p<.001). Screw position according to the Heary scale was Grade II (4 navigated surgery, 6 fluoroscopy guided), Grade III (3 navigated surgery, 11 fluoroscopy guided), Grade IV (4 navigated surgery, 16 fluoroscopy guided), and Grade V (1 fluoroscopy guided). There was only one symptomatic case in the conventional surgery group. Breach severity was seven Grade A and four Grade B in the navigated surgery group, and eight Grade A, 24 Grade B, and one Grade C in free-hand fluoroscopy-guided surgery group. Radiation received per patient was 5.8 mSv (4.8-7.3). The median dose received in the free-hand fluoroscopy group was 1 mGy (0.8-1.1). There was no detectable radiation level in the navigation-assisted surgery group, whereas the effective dose was 10 µGy in the free-hand fluoroscopy-guided surgery group.

Conclusions: Malposition rate, both symptomatic and asymptomatic, in spinal surgery is reduced when using CT-guided placement of transpedicular instrumentation compared with placement under fluoroscopic guidance, with radiation values within the safety limits for health. Larger studies are needed to determine risk-benefit in these patients.
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http://dx.doi.org/10.1016/j.spinee.2016.08.004DOI Listing
January 2017

Long-Term Benefits of Percutaneous Anatomical Restoration of Vertebral Compression Fractures Linked to Malignancy.

Turk Neurosurg 2016;26(4):608-14

Valladolid University Hospital, Spine Unit, Department of Orthopedic, Valladolid, Spain.

Aim: To evaluate the efficacy, feasibility and safety of a percutaneous anatomical vertebral body reduction for the treatment of VCF (vertebral compression fracture) linked to malignancy. Vertebroplasty and percutaneous kyphoplasty have played essential roles in the treatment of painful vertebral metastasis, although there are few reports with long survival that have evaluated the long-term efficacy, adjacent fractures and vertebral body (VB) re-collapse associated with these procedures. We aimed to evaluate the longterm efficacy and the complications associated with malignancy and changes in spinal biomechanics.

Material And Methods: The retrospective study examined 32 patients with osteolytic VCF due to malignant infiltration of the vertebral body. A visual analogue scale, the EQ5 and radiological analysis (i.e., X-ray and CT scan) were used to assess back pain, quality of life and complications.

Results: Statistically significant reductions in anterior and central vertebral body heights (6.2 mm-19.6 ± 4.2 mm- and 5.8 mm- 16.7 ± 7.8 mm-, respectively) that resulted in reductions of the regional Cobb angles exceeding 30% were observed. There was also a statistically significant improvement in quality of life. The average survival was longer than those reported in most published articles, and the average follow-up period was 30.9 months.

Conclusion: Anatomical restoration (i.e., cortical ring reduction with endplate rebalancing) is potentially beneficial for a wellselected group of patients with spine metastases and long life expectancies because this procedure avoids the complications typical of these types of treatments (e.g., leakage, adjacent fractures and re-collapse).
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http://dx.doi.org/10.5137/1019-5149.JTN.12294-14.1DOI Listing
December 2016

Diffusion-Weighted MRI Assessment of Adjacent Disc Degeneration After Thoracolumbar Vertebral Fractures.

Cardiovasc Intervent Radiol 2016 Sep 1;39(9):1306-14. Epub 2016 Jun 1.

Department of Radiology, Azienda Ospedaliero Universitaria (A.O.U.), di Cagliari - Polo di Monserrato s.s. 554, 09045, Monserrato, Cagliari, Italy.

Objective: The purpose of this study was to assess, by the mean apparent diffusion coefficient (ADC), if a relationship exists between disc ADC and MR findings of adjacent disc degeneration after thoracolumbar fractures treated by anatomic reduction using vertebral augmentation (VAP).

Materials And Methods: Twenty non-consecutive patients (mean age 50.7 years; range 45-56) treated because of vertebral fractures, were included in this study. There were 10 A3.1 and 10 A1.2 fractures (AO classification). Surgical treatment using VAP was applied in 14 cases, and conservative in 6 patients. MRI T2-weighted images and mapping of apparent diffusion coefficient (ADC) of the intervertebral disc adjacent to the fractured segment were performed after a mean follow-up of 32 months. A total of 60 discs, 3 per patient, were analysed: infra-adjacent, supra-adjacent and a control disc one level above the supra-adjacent.

Results: No differences between patients surgically treated and those following a conservative protocol regarding the average ADC values obtained in the 20 control discs analysed were found. Considering all discs, average ADC in the supra-adjacent level was lower than in the infra-adjacent (1.35 ± 0.12 vs. 1.53 ± 0.06; p < 0.001). Average ADC values of the discs used as a control were similar to those of the infra-adjacent level (1.54 ± 0.06). Compared to surgically treated patients, discs at the supra-adjacent fracture level showed statistically significant lower values in cases treated conservatively (p < 0.001). The variation in the delay of surgery had no influence on the average values of ADC at any of the measured levels.

Conclusions: ADC measurements of the supra-adjacent discs after a mean follow-up of 32 months following thoracolumbar fractures, showed that restoration of the vertebral collapse by minimally invasive VAP prevents posttraumatic disc degeneration.
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http://dx.doi.org/10.1007/s00270-016-1369-3DOI Listing
September 2016

Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

Biomed Res Int 2015 12;2015:927813. Epub 2015 Jan 12.

Department of Spine Surgery, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany ; Department of Spine Surgery, Bad Bramstedt Clinic, 24576 Bad Bramstedt, Germany.

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.
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http://dx.doi.org/10.1155/2015/927813DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309217PMC
September 2015

Melatonin in epilepsy and febrile seizures.

J Child Neurol 2010 Jul 26;25(7):888-91. Epub 2010 May 26.

Chronobiology Research Group, University of Valladolid School of Medicine, Valladolid, Spain.

A study on melatonin rhythm in children with generalized idiopathic epilepsy and simple fever is presented in this article. A population of 40 children was divided into 4 groups, namely, epilepsy, febrile seizure, and 2 control groups. Salivary melatonin was measured by means of radioimmunoassay. Friedman 2-way analysis of variance (ANOVA) and Wilcoxon tests were employed to assess the existence of melatonin rhythm. Comparison across groups was performed by means of ANOVA and Mann-Whitney tests. Higher melatonin levels were found at night, with a peak at 04:00 h in all groups. Significant diurnal rhythm was also detected for these levels. No significant overall differences between case and control groups were found for melatonin levels, though patients showed lower peak melatonin values than controls at 04:00 h with a significant difference in the febrile seizure group (10.70 vs 19.5 pg/mL respectively; P<.04). Our data support the presence of diurnal rhythm in blood melatonin concentrations in children with epileptic and febrile seizures. Comparison between case and control groups showed lower peak concentrations in the febrile seizure group with respect to healthy controls.
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http://dx.doi.org/10.1177/0883073809351315DOI Listing
July 2010
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