Publications by authors named "David C Noriega"

12 Publications

  • Page 1 of 1

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

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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February 2021

Misaligned spinal rods can induce high internal forces consistent with those observed to cause screw pullout and disc degeneration.

Spine J 2021 03 30;21(3):528-537. Epub 2020 Sep 30.

Department of Orthopaedic Surgery, Laboratory for Experimental Orthopaedics, CAPHRI, Maastricht University Medical Centre, Maastricht, the Netherlands; Department of Biomedical Engineering, Orthopaedic Biomechanics, Eindhoven University of Technology, Eindhoven, the Netherlands. Electronic address:

Background Context: Manual contouring of spinal rods is often required intraoperatively for proper alignment of the rods within the pedicle screw heads. Residual misalignments are frequently reduced by using dedicated reduction devices. The forces exerted by these devices, however, are uncontrolled and may lead to excessive reaction forces. As a consequence, screw pullout might be provoked and surrounding tissue may experience unfavorable biomechanical loads. The corresponding loads and induced tissue deformations are however not well identified. Additionally, whether the forced reduction alters the biomechanical behavior of the lumbar spine during physiological movements postoperatively, remains unexplored.

Purpose: To predict whether the reduction of misaligned posterior instrumentation might result in clinical complications directly after reduction and during a subsequent physiological flexion movement.

Study Design: Finite element analysis.

Methods: A patient-specific, total lumbar (L1-S1) spine finite element model was available from previous research. The model consists of poro-elastic intervertebral discs with Pfirrmann grade-dependent material parameters, with linear elastic bone tissue with stiffness values related to the local bone density, and with the seven major ligaments per spinal motion segment described as nonlinear materials. Titanium instrumentation was implemented in this model to simulate a L4, L5, and S1 posterolateral fusion. Next, coronal and sagittal misalignments of 6 mm each were introduced between the rod and the screw head at L4. These misalignments were computationally reduced and a physiological flexion movement of 15° was prescribed. Non-instrumented and well-aligned instrumented models were used as control groups.

Results: Pulling forces up to 1.0 kN were required to correct the induced misalignments of 6 mm. These forces affected the posture of the total lumbar spine, as motion segments were predicted to rotate up to 3 degrees and rotations propagated proximally to and even affect the L1-2 level. The facet contact pressures in the corrected misaligned models were asymmetrical suggesting non-physiological joint loading in the misaligned models. In addition, the discs and vertebrae experienced abnormally high forces as a result of the correction procedure. These effects were more pronounced after a 15° flexion movement following forced reduction.

Conclusions: The results of this study indicate that the correction of misaligned posterior instrumentation can result in high forces at the screws consistent with those reported to cause screw pullout, and may cause high-tissue strains in adjacent and downstream spinal segments.

Clinical Significance: Proper alignment of spinal posterior instrumentation may reduce clinical complications secondary to unfavorable biomechanics.
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March 2021

Influence of HLA Matching on the Efficacy of Allogeneic Mesenchymal Stromal Cell Therapies for Osteoarthritis and Degenerative Disc Disease.

Transplant Direct 2017 Sep 17;3(9):e205. Epub 2017 Aug 17.

Infection and Immunity Medical Investigation Unit (IMI), Microbiology and Immunology Service, Valladolid University Clinic Hospital, Valladolid, Spain.

Background: The necessity for more effective therapies for chronic osteoarticular diseases has led to the development of treatments based on mesenchymal stem cells (MSCs), the natural precursors of musculoskeletal tissue. Treatments with autologous MSCs yielded excellent results, with nearly 70% improvement of pain and disability in osteoarthritis and degenerative disc disease. Using allogeneic MSCs is logistically more convenient and would widen the pool of eligible patients, but potential immune rejection should be considered. In this context, MSCs are purportedly immune evasive and better tolerated than other cell types.

Methods: We used samples collected during the performance of 2 randomized clinical trials using allogeneic bone marrow MSCs for treatment of osteoarthritis (NCT01586312) and degenerative disc disease (NCT01860417). Serum samples were used to determine anti-HLA antibodies, whereas either blood or MSC samples were used for HLA typing of recipients and donors, respectively. Algofunctional indexes were used as indicators of clinical evolution, and the correlation between the number of donor-host HLA mismatches and the efficacy of treatment was determined.

Results: Immune response was weak and transient, with reactivity decaying during the first year. Consistently, better donor-recipient HLA matching did not enhance efficacy.

Conclusions: This lack of reactivity is presumably due to the cooperation of 2 factors, (1) downregulation of the host immune responses by the transplanted MSCs and (2) effective insulation of these cells inside the articular cavity or the intervertebral disc, respectively. Interestingly, better HLA matching did not enhance efficacy. These observations have medical relevance as they support the clinical use of allogeneic cells, at least as a single-dose administration. Multiple-dose applications will require further research to exclude possible sensitization.
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September 2017

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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September 2017

Long-Term Outcomes of Posterior Lumbar Interbody Fusion Using Stand-Alone Ray Threaded Cage for Degenerative Disk Disease: A 20-Year Follow-Up.

Asian Spine J 2016 Dec 8;10(6):1100-1105. Epub 2016 Dec 8.

Spine Unit, Valladolid University Hospital, Royal Academy of Medicine and Surgery, Valladolid, Spain.

Study Design: Retrospective study.

Purpose: To analyze outcomes of posterior lumbar interbody fusion (PLIF) stand-alone cages.

Overview Of Literature: PLIF for degenerative disk disease using stand-alone cages has lost its popularity owing to implant-related complications and pseudoarthrosis.

Methods: We analyzed the records of 45 patients (18 women, 27 men), operated between January 1994 and December 1996, with a mean follow-up of 18 years 3 months (20 years 3 months-22 years 3 months). Clinical outcomes were measured using visual analogue score (VAS), Oswestry disability index (ODI), Odom's criteria, and radiological measurements of fusion rate, Cobb angle, and implant-related complications conducted at the preoperative evaluation, hospital discharge, 12-month follow-up, and final follow-up.

Results: Preoperative mean VAS (back) was 6.9 and VAS (radicular) was 7.2, with mean improvements ( <0.05) of 2.9 and 3.1, respectively, at the final follow-up. Median preoperative ODI was 64.5, with a mean improvement to 34 and 42 at the 12-month and final follow-ups, respectively ( <0.05). Odom's criteria at the 12-month follow-up were excellent in 11.2% patients, good in 57.7%, fair in 31.1%, and poor in none of the patients; at the final follow-up, no patient was classified as excellent, 71.1% as good, 22.2% as fair, and 6.7% as poor ( <0.05). Pseudoarthrosis was observed in five patients (11.1%), of whom, three (6.6%) required re-operation. Preoperative disk height was 9.23 mm, which increased to 13.33 mm in the immediate postoperative evaluation and was maintained at 10.0 mm at the final follow-up ( <0.05). The preoperative mean L1-S1 Cobb angle was 34.7°, which changed to 44.7° in the immediate postoperative evaluation and dropped to 39.7° at the final follow-up ( <0.005).

Conclusions: PLIF stand-alone cages were associated with good clinical outcomes. Although the fusion rate was excellent, maintenance of disk heights and a lordotic alignment were not achieved in the long term.
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December 2016

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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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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January 2017

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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September 2016

Percutaneous Dorsal Instrumentation of Vertebral Burst Fractures: Value of Additional Percutaneous Intravertebral Reposition-Cadaver Study.

Biomed Res Int 2015 2;2015:434873. Epub 2015 Jun 2.

Department of Trauma, Hand and Reconstructive Surgery, Philipps University, 35043 Marburg, Germany.

Purpose: The treatment of vertebral burst fractures is still controversial. The aim of the study is to evaluate the purpose of additional percutaneous intravertebral reduction when combined with dorsal instrumentation.

Methods: In this biomechanical cadaver study twenty-eight spine segments (T11-L3) were used (male donors, mean age 64.9 ± 6.5 years). Burst fractures of L1 were generated using a standardised protocol. After fracture all spines were allocated to four similar groups and randomised according to surgical techniques (posterior instrumentation; posterior instrumentation + intravertebral reduction device + cement augmentation; posterior instrumentation + intravertebral reduction device without cement; and intravertebral reduction device + cement augmentation). After treatment, 100000 cycles (100-600 N, 3 Hz) were applied using a servohydraulic loading frame.

Results: Overall anatomical restoration was better in all groups where the intravertebral reduction device was used (p < 0.05). In particular, it was possible to restore central endplates (p > 0.05). All techniques decreased narrowing of the spinal canal. After loading, clearance could be maintained in all groups fitted with the intravertebral reduction device. Narrowing increased in the group treated with dorsal instrumentation.

Conclusions: For height and anatomical restoration, the combination of an intravertebral reduction device with dorsal instrumentation showed significantly better results than sole dorsal instrumentation.
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March 2016

The efficacy of a percutaneous expandable titanium device in anatomical reduction of vertebral compression fractures of the thoracolumbar spine.

Saudi Med J 2015 Jan;36(1):52-60

Division of Neurosurgery, Faculty of Medicine, King Abdulaziz University, PO Box 80215, Jeddah 21589, Kingdom of Saudi Arabia. Fax. +966 (12) 6408469. E-mail.

Objectives: To evaluate the feasibility of a minimally invasive technique using a titanium expandable device to achieve anatomical restoration of vertebral compression fractures (VCF) of the thoracolumbar spine.

Methods: This prospective study included 27 patients diagnosed with VCF (Magerl classification A.1.2, A.1.3, and A.3.1) of the thoracolumbar spine treated with percutaneous cement augmentation using the SpineJack® device. The study was conducted in Valladolid University Hospital, Valladolid, Spain from January to December 2012, with a minimum one-year follow up. Preoperative evaluation included visual analogue scale (VAS) for pain, and radiological assessment of the VCF using 3-dimensional computed tomography (3D-CT) scans for measurements of vertebral heights and angles. The patients were followed at 3, 6, and 12 months with clinical VAS and radiological assessments.

Results: The procedure was performed in 27 patients with a mean age of 55.9 ± 17.3 years, 55.6% females. All patients underwent surgery within 6 weeks from time of injury. No procedure related complications occurred. Pain measured by VAS score decreased from 7.0 preoperatively to 3.2 within 24 hours, and remained 2.2 at 3 months, 2.1 at 6 months, and 1.5 at 12-months follow-up (p<0.05). Mean height restorations for the anterior was 3.56 mm, central was 2.49, and posterior vertebral was 1.28 mm, and maintained at 12-months follow-up (p=0.001).

Conclusion: This new percutaneous technique for VCF has shown good clinical results in pain control and the possibility to reduce both vertebral kyphosis angles and fractured endplates seen in 3D-CT scans assessment method. Further studies are needed to confirm those results on larger cohorts with long-term follow up. 
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January 2015

Height restoration of osteoporotic vertebral compression fractures using different intravertebral reduction devices: a cadaveric study.

Spine J 2015 May 5;15(5):1092-8. Epub 2013 Nov 5.

Department of Trauma and Reconstructive Surgery Philipps University of Marburg, University Hospital Giessen and Marburg, Baldingerstrasse, 35043 Marburg, Germany.

Background: The treatment of osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly during the past two decades. Balloon kyphoplasty was developed to restore vertebral height and improve sagittal alignment. Several studies have shown these theoretical improvements cannot be transferred universally to the clinical setting.

Purpose: The aim of the current study is to evaluate two different procedures used for percutaneous augmentation of vertebral compression fractures with respect to height restoration: balloon kyphoplasty and SpineJack.

Materials And Methods: Twenty-four vertebral bodies of two intact, fresh human cadaveric spines (T6-L5; donor age, 70 years and 60 years; T-score -6.8 points and -6.3 points) were scanned using computed tomography (CT) and dissected into single vertebral bodies. Vertebral wedge compression fractures were created by a material testing machine (Universal testing machine, Instron 5566, Darmstadt, Germany). The axial load was increased continuously until the height of the anterior edge of the vertebral body was reduced by 40% of the initial measured values. After 15 minutes, the load was decreased manually to 100 N. After postfracture CT, the clamped vertebral bodies were placed in a custom-made loading frame with a preload of 100 N. Twelve vertebral bodies were treated using SpineJack (SJ; Vexim, Balma, France), the 12 remaining vertebral bodies were treated with balloon kyphoplasty (BKP; Kyphon, Medtronic, Sunnyvale, CA, USA). The load was maintained during the procedure until the cement set completely. Posttreatment CT was performed. Anterior, central, and posterior height as well as the Beck index were measured prefracture and postfracture as well as after treatment.

Results: For anterior height restoration (BKP, 0.14±1.48 mm; SJ, 3.34±1.19 mm), central height restoration (BKP, 0.91±1.04 mm; SJ, 3.24±1.22 mm), and posterior restoration (BKP, 0.37±0.57 mm; SJ, 1.26±1.05), as well as the Beck index (BKP, 0.00±0.06 mm; SJ, 0.10±0.06), the values for the SpineJack group were significantly higher (p<.05) CONCLUSION: The protocols for creating wedge fractures and using the instrumentation under a constant preload of 100 N led to reproducible results and effects. The study showed that height restoration was significantly better in the SpineJack group compared with the balloon kyphoplasty group. The clinical implications include a better restoration of the sagittal balance of the spine and a reduction of the kyphotic deformity, which may relate to clinical outcome and the biological healing process.
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May 2015