Cementless Fixation of Osteoporotic VCFs Using Titanium Mesh Implants (OsseoFix): Preliminary Results

BioMed Research International ◽

10.1155/2014/853897 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 7

Author(s):

Anica Eschler ◽

Stephan Albrecht Ender ◽

Benjamin Ulmar ◽

Philipp Herlyn ◽

Thomas Mittlmeier ◽

...

Keyword(s):

Perioperative Complications ◽

Cement Leakage ◽

Minimal Invasive ◽

Vertebral Compression Fractures ◽

Titanium Mesh ◽

Cementless Fixation ◽

Preliminary Results ◽

Bony Healing ◽

Adjacent Fractures

Introduction. Vertebral compression fractures (VCFs) affect 20% of people over the age of 70 with increasing incidence. Kypho-/vertebroplasty as standard operative procedures are associated with limitations like cement leakage, limited reduction capabilities, and risk for adjacent fractures. To address these shortcomings, we introduce a new minimal invasive cementless VCF fixation technique.Methods. Four patients (72.3 years, range 70–76) with VCFs type AO/Müller A1.3 and concomitant osteoporosis were treated by minimal invasive transpedicular placement of two intervertebral mesh cages for fracture reduction and maintenance. Follow-up included functional/radiological assessment and clinical scores and averaged 27.7 months (24–28).Results. Endplate reduction was achieved in all cases (mean surgery time: 28.5 minutes). Kyphotic (KA) and Cobb angle revealed considerable improvements postoperatively (KA 14.5° to 10.7°/Cobb 10.1° to 8.3°). Slight loss of vertebral reduction (KA: 12.6°) and segment rekyphosis (Cobb: 10.7°) were observed for final follow-up. Pain improved from 8.8 to 2.8 (visual analogue scale). All cases showed signs of bony healing. No perioperative complications and no adjacent fractures occurred.Conclusion. Preliminary results in a small, selected patient collective indicate the ability of bony healing for osteoporotic VCFs. Cementless fixation using intravertebral titanium mesh cages revealed substantial pain relief, adequate reduction, and reduction maintenance without complications. Trial registration number is DRKS00005657, German Clinical Trials Register (DKRS).

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Cementless Titanium Mesh Fixation of Osteoporotic Burst Fractures of the Lumbar Spine Leads to Bony Healing: Results of an Experimental Sheep Model

BioMed Research International ◽

10.1155/2016/4094161 ◽

2016 ◽

Vol 2016 ◽

pp. 1-9 ◽

Cited By ~ 4

Author(s):

Anica Eschler ◽

Paula Roepenack ◽

Jan Roesner ◽

Philipp Karl Ewald Herlyn ◽

Heiner Martin ◽

...

Keyword(s):

Intraoperative Complications ◽

Mesh Fixation ◽

Fracture Reduction ◽

Vertebral Compression Fractures ◽

Micro Ct ◽

Titanium Mesh ◽

Deficient Diet ◽

Sheep Model ◽

Bony Healing ◽

Bony Consolidation

Introduction. Current treatment strategies for osteoporotic vertebral compression fractures (VCFs) focus on cement-associated solutions. Complications associated with cement application are leakage, embolism, adjacent fractures, and compromise in bony healing. This study comprises a validated VCF model in osteoporotic sheep in order to (1) evaluate a new cementless fracture fixation technique using titanium mesh implants (TMIs) and (2) demonstrate the healing capabilities in osteoporotic VCFs.Methods. Twelve 5-year-old Merino sheep received ovariectomy, corticosteroid injections, and a calcium/phosphorus/vitamin D-deficient diet for osteoporosis induction. Standardized VCFs (type AO A3.1) were created, reduced, and fixed using intravertebral TMIs. Randomly additional autologous spongiosa grafting (G1) or no augmentation was performed (G2,n=6each). Two months postoperatively, macroscopic, micro-CT and biomechanical evaluation assessed bony consolidation.Results. Fracture reduction succeeded in all cases without intraoperative complications. Bony consolidation was proven for all cases with increased amounts of callus development for G2 (58.3%). Micro-CT revealed cage integration. Neither group showed improved results with biomechanical testing.Conclusions. Fracture reduction/fixation using TMIs without cement in osteoporotic sheep lumbar VCF resulted in bony fracture healing. Intravertebral application of autologous spongiosa showed no beneficial effects. The technique is now available for clinical use; thus, it offers an opportunity to abandon cement-associated complications.

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A second puncture and injection technique for treating osteoporotic vertebral compression fractures

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-019-1498-x ◽

2019 ◽

Vol 14 (1) ◽

Author(s):

Zhaofei Zhang ◽

Feng Jiao ◽

He Huang ◽

Yonghui Feng ◽

Chunliang Xie ◽

...

Keyword(s):

Vertebral Fractures ◽

Cement Leakage ◽

Vertebral Compression Fractures ◽

Injection Technique ◽

Vertebral Height ◽

Vas Score ◽

Injection Group ◽

Group A ◽

Group B

Abstract Objective To evaluate the clinical effect of the second puncture and injection technique during a percutaneous vertebroplasty (PVP) procedure. Methods Patients treated with a second puncture and injection (group A) or a single puncture and injection (group B) during PVP at our institution during 2010–2017 were reviewed. Vertebral height loss, visual analogue scale (VAS) score, Oswestry disability index (ODI), adjacent vertebral fractures, and cement leakage were compared between the groups. Results A total of 193 patients were enrolled (86 cases in group A, 107 cases in group B). The follow-up period was 15.64 (12–20) months. The loss of anterior (group A 0.01 ± 0.03; group B 0.14 ± 0.17) and middle (group A 0.13 ± 0.12; group B 0.16 ± 0.11) vertebral height in group B was significantly higher than that in group A (P < 0.05). The VAS score and ODI were also significantly higher in group B than in group A at the final follow-up; the VAS score and ODI in group B were 1.65 ± 0.70 and 14.50 ± 4.16, respectively, and those in group A were 1.00 ± 0.74 and 12.81 ± 4.02, respectively (P < 0.05). Three patients in group A and two in group B experienced adjacent vertebral fractures. Regarding mild, moderate, and severe cement leakage, there were 25 (29%), 5 (5%), and 0 cases, respectively, in group A and 28 (26%), 3 (2.8%), and 1 (0.009%) case, respectively, in group B (P > 0.05). Conclusions The second puncture and injection technique may effectively increase the dispersion of cement, thus preventing recompression of the cemented vertebral body, and it does not increase the risk of cement leakage or adjacent vertebral fracture.

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Intravertebral Vacuum Cleft and Its Varied Locations within Osteoporotic Vertebral Compression Fractures: Effect on Therapeutic Efficacy

January 2018 - Pain Physician ◽

10.36076/ppj.20.5.e979 ◽

2017 ◽

Vol 6 (20;6) ◽

pp. E979-E986

Author(s):

Xiaobing Jiang

Keyword(s):

Therapeutic Efficacy ◽

Body Height ◽

Cement Leakage ◽

Vertebral Compression Fractures ◽

Osteoporotic Vertebral Compression Fractures ◽

Compression Fractures ◽

Number Of Patients ◽

Significant Difference

Background: Previous studies have reported a high incidence of re-collapse of the augmented vertebrae after percutaneous vertebral augmentation (PVA) for osteoporotic vertebral compression fractures (OVCFs) with intravertebral vacuum cleft (IVC) during long-term followup. Previous IVC might be considered an important predisposing factor for re-collapse, but the prior studies could not find a significant correlation. Objective: To determine the incidence and distribution characteristics of IVCs and to further assess IVCs in their varied locations. To assess the long-term therapeutic efficacy of PVA for OVCFs with IVC. Study Design: A retrospective cohort study. Setting: Department of spinal surgery, an affiliated hospital of a medical university. Methods: A retrospective review was performed on 594 patients who underwent PVA to treat OVCFs from January 2010 to December 2013. Eighty-two patients with the IVC sign were enrolled in the study. The follow-up period was a minimum of 2 years. The difference between IVC and non-IVC patients was compared. Comparisons of the radiological and clinical findings at varied IVC locations were made pre-operatively and post-operatively (immediate, at one year, and at 2 years). Results: IVC incidence correlated with older patient age and severe demineralization. Other baseline parameters showed no significant differences. The rate of cement leakage and vertebral fracture was significantly lower in the IVC groups than in the non-IVC groups intraoperatively. There was no significant difference in the incidence of cement leakage or adjacent vertebral fractures between the 3 IVC groups. In the immediate postoperative period, all patients benefited from significant improvement in vertebral body height and kyphotic angle correction. However, significant re-collapse was observed at the 2-year post-operative followup for the IVC patients when compared to the non-IVC patients. Among the 3 IVC groups, the most severe re-collapse was observed with inferior endplate IVCs. Superior endplate IVCs and IVCs extending to both endplates demonstrated only mild re-collapse at the 2-year follow-up. Limitation: Due to the infrequency of this process, the number of patients with IVCs was small. Conclusion: PVA treatment was initially effective in all patients with OVCFs. However, significant re-collapse of the augmented vertebrae with IVCs, especially those with inferior endplate IVCs, was found with long-term follow-up.

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Comparison of percutaneous vertebroplasty with a side-hole push rod and conventional percutaneous vertebroplasty for the treatment of OVCFs

10.21203/rs.3.rs-32093/v1 ◽

2020 ◽

Author(s):

Zhengshuai Jin ◽

Hailong Zhou ◽

Xuefei Yan ◽

Chunming Wang ◽

Yuanqing Mao ◽

...

Keyword(s):

Bone Cement ◽

Operative Time ◽

Percutaneous Vertebroplasty ◽

Cement Leakage ◽

Vertebral Compression Fractures ◽

Postoperative Results ◽

Injection Volume ◽

Side Hole ◽

Cement Injection

Abstract ObjectiveThe aim of this study was to compare the clinical efficacy of percutaneous vertebroplasty with a side-hole push rod (modified PVP) and conventional PVP in treating osteoporotic vertebral compression fractures (OVCFs).Materials and methodsThis study included 69 patients with 1-level OVCFs. Perioperative indicators, including the operative time, cement injection volume, cement leakage rate, and distribution of cement in the fractured area, were analysed. The visual analogue scale (VAS) and Oswestry disability index (ODI) were administered pre- and postoperatively.ResultsNo significant differences were observed in the operative time or cement injection volume between the two groups (p > 0.05). The total diffusion score of bone cement in the PVP group was significantly lower than that in the modified PVP group (p < 0.05). Compared with the conventional PVP group, the modified PVP group had a significantly lower VAS score at 3 days postoperatively (p < 0.05). There were no differences in the VAS or ODI scores between the two groups at the last follow-up (p > 0.05). Bone cement leakage was observed in 15 cases in the conventional PVP group (15/32) and in 9 cases in the modified PVP group (9/37).ConclusionThe modified version of PVP provides sufficient cement to fill the fractured area and is associated with a lower incidence of cement leakage and undesired postoperative results than is conventional PVP, indicating that modified PVP is a safe and effective new technique for the treatment of OVCFs.

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Creation of a planned or central-clefted puncture combined with a second puncture during vertebroplasty to treat osteoporotic vertebral compression fractures with large clefts

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-020-02048-z ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Chi Li ◽

Yang Zhou ◽

Min-yu Zhu ◽

Yu Wang ◽

Zheng-mao Zhang ◽

...

Keyword(s):

Cement Leakage ◽

Vertebral Compression Fractures ◽

Osteoporotic Vertebral Compression Fractures ◽

Compression Fractures ◽

Pain Scores ◽

Significant Difference ◽

Dispersion Patterns ◽

Group A ◽

Group B

Abstract Background Cemented vertebrae frequently re-fracture after vertebroplasty to treat osteoporotic vertebral compression fractures (OVCFs) with large clefts. We compared the efficacy of planned and central-clefted puncture, both followed by a second puncture, as treatments for OVCFs with large clefts. Methods We retrospectively studied 38 patients. 18 of whom underwent planned puncture (group A) and 20 central-clefted puncture (group B). A second puncture was performed when the initially injected cement was restricted to the cleft. We recorded a visual analog scale (VAS) pain scores, vertebral kyphotic angles (KAs), and compression ratios (CRs) preoperatively and at 2 days and 6 months postoperatively. We recorded the cement dispersion patterns and complications. Results Second punctures succeeded in 15/18 and 7/20 patients of groups A and B, respectively. At 2 days postoperatively, the VAS score, KA, and CR were significantly better than the preoperative values (P < 0.01); no significant difference was found between the two groups (P > 0.05). At the 6-month follow-up, all scores were poorer than at 2 days postoperatively (all P < 0.05), significantly more so in group B than group A (P < 0.05). Significant differences in terms of the cement dispersion patterns, and the cemented vertebral re-fracture and cement leakage rates, were observed between the two groups (all P < 0.05). Conclusion The two-puncture techniques were initially effective when treating large-clefted OVCFs. However, compared to the central-clefted puncture, the planned puncture improved the success rate of the second puncture, allowed better cement dispersion, and reduced the incidence of vertebral re-fracture during follow-up.

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Percutaneous kyphoplasty for osteoporotic vertebral compression fractures via unilateral versus bilateral approach

10.21203/rs.3.rs-18059/v1 ◽

2020 ◽

Author(s):

Wenye Yao ◽

Bin Zhang ◽

Qi Lai ◽

Song Gao ◽

Runsheng Guo

Keyword(s):

Bone Cement ◽

Operative Time ◽

Cement Leakage ◽

Leakage Rate ◽

Vertebral Compression Fractures ◽

Osteoporotic Vertebral Compression Fractures ◽

Compression Fractures ◽

Bilateral Approach ◽

Unilateral Group

Abstract Objective To evaluate the efficacy of percutaneous kyphoplasty (PKP) for thoracolumbar osteoporotic vertebral compression fractures (OVCFs) via unilateral versus bilateral approach. Methods All patients who underwent PKP surgery for OVCFs in our hospital between June 2016 and December 2018 were included in this study. The pedicles were divided into two groups according to the manner of vertebral body puncture, which were as follows: unilateral pedicle puncture group (unilateral group, n=47) and bilateral pedicle puncture group (bilateral group, n=39).The operative time, amount of cement perfusion, correction angle of kyphosis, pain score before and after surgery, and leakage rate of bone cement were evaluated in all patients. The average follow-up was 19 months (range 13-34 months). Results The average age of patients who met the inclusion criteria, but not the exclusion criteria, was 76 years, and a total of 121 vertebral bodies were studied. There were 7 cases of postoperative bone cement leakage (unilateral group, 14.9%) and 6 cases of postoperative bone cement leakage (bilateral groups, 15.4%). There were differences in operative time and amount of cement perfusion between the two groups were statistically significant (P<0.05). There was no significant increase in age, body mass index, pain index during follow-up, treatment outcome, correction angle of kyphosis, and cement leakage rate between the two groups (P>0.05). Moreover, there was no significant difference in sex and bone cement leakage rate between the two groups by Pearson x 2 test (P>0.05). Conclusion Patients with OVCFs could obtain similar satisfactory clinical results via both unilateral and bilateral PKP approaches. However, the unilateral PKP approach is more advantageous as it has a shorter operative time, requires lesser cement volume, causes minimal trauma, is less costly, and results in lesser complications than the bilateral approach.

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Analysis of risk factors causing short-term cement leakages and long-term complications after percutaneous kyphoplasty for osteoporotic vertebral compression fractures

Acta Radiologica ◽

10.1177/0284185117725368 ◽

2017 ◽

Vol 59 (5) ◽

pp. 577-585 ◽

Cited By ~ 8

Author(s):

Chang Gao ◽

Min Zong ◽

Wen-tao Wang ◽

Lei Xu ◽

Da Cao ◽

...

Keyword(s):

Risk Factors ◽

Cement Leakage ◽

Vertebral Compression Fractures ◽

Osteoporotic Vertebral Compression Fractures ◽

Short Term ◽

Additional Risk ◽

Compression Fractures ◽

Strong Risk Factor

Background Percutaneous kyphoplasty (PKP) is a common treatment modality for painful osteoporotic vertebral compression fractures (OVCFs). Pre- and postoperative identification of risk factors for cement leakage and follow-up complications would therefore be helpful but has not been systematically investigated. Purpose To evaluate pre- and postoperative risk factors for the occurrence of short-term cement leakages and long-term complications after PKP for OVCFs. Material and Methods A total of 283 vertebrae with PKP in 239 patients were investigated. Possible risk factors causing cement leakage and complications during follow-up periods were retrospectively assessed using multivariate analysis. Cement leakage in general, three fundamental leakage types, and complications during follow-up period were directly identified through postoperative computed tomography (CT). Results Generally, the presence of cortical disruption ( P = 0.001), large volume of cement ( P = 0.012), and low bone mineral density (BMD) ( P = 0.002) were three strong predictors for cement leakage. While the presence of intravertebral cleft and Schmorl nodes ( P = 0.045 and 0.025, respectively) were respectively identified as additional risk factors for paravertebral and intradiscal subtype of cortical (C-type) leakages. In terms of follow-up complications, occurrence of cortical leakage was a strong risk factor both for new VCFs ( P = 0.043) and for recompression ( P = 0.004). Conclusion The presence of cortical disruption, large volume of cement, and low BMD of treated level are general but strong predictors for cement leakage. The presence of intravertebral cleft and Schmorl nodes are additional risk factors for cortical leakage. During follow-up, the occurrence of C-type leakage is a strong risk factor, for both new VCFs and recompression.

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Balloon Kyphoplasty for Acute Osteoporotic Compression Fractures

Interventional Neuroradiology ◽

10.1177/159101991001600108 ◽

2010 ◽

Vol 16 (1) ◽

pp. 65-70 ◽

Cited By ~ 1

Author(s):

T. Yang ◽

S. Liu ◽

X. Lv ◽

Z. Wu

Keyword(s):

Invasive Procedure ◽

Balloon Kyphoplasty ◽

Cement Leakage ◽

Vertebral Compression Fractures ◽

Minimally Invasive Procedure ◽

Compression Fractures ◽

Low Incidence ◽

Initial Score ◽

Cement Extravasation

We reviewed the effectiveness of balloon kyphoplasty in the treatment of acute symptomatic vertebral compression fractures. We assessed radiographic and functional outcome in 11 patients with a 24.3 month follow-up from a retrospectively monitored series of 11 patients who underwent balloon kyphoplasty (BKP). A visual analogue scale (VAS) and the short McGill questionnaire (MPQ) were used to assess average symptoms. Eleven patients with 19 treated vertebrae completed the study. The VAS showed significant improvement after treatment: the initial score was 9.1 ± 0.6 (mean ± SD), falling to 2.7 ± 1.07 by 24.3 months (P<0.001). The MPQ also showed a significant improvement (P<0.001) at follow-up. A new fracture was seen in one patient affecting two vertebrae adjacent to the treated level. On CT following the procedure, there was cement leakage in the disc in 9% of cases. BKP is a minimally invasive procedure that has been shown to be effective in the treatment of acute symptomatic vertebral compression fractures. It appears that BKP is associated with a low incidence of procedure-related complications and cement extravasation.

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Comparison of High-Viscosity Cement Vertebroplasty and Balloon Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures

January 2018 - Pain Physician ◽

10.36076/ppj/2015.18.e187 ◽

2015 ◽

Vol 2;18 (2;3) ◽

pp. E187-E194

Author(s):

Lin Nie

Keyword(s):

Balloon Kyphoplasty ◽

Cement Leakage ◽

High Viscosity ◽

Leakage Rate ◽

Vertebral Compression Fractures ◽

Osteoporotic Vertebral Compression Fractures ◽

Vertebral Height ◽

Compression Fractures ◽

One Year

Background: Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures (OVCFs). But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use. Balloon kyphoplasty (BKP) and high-viscosity cement vertebroplasty (HVCV) are 2 modifications of vertebroplasty designed to decrease cement leakage. Objective: To assess the safety and efficacy of HVCV compared with BKP. Study Design: A prospective cohort study. Setting: Department of Spine Surgery, an affiliated hospital of a medical university. Method: One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), cement leakage, and vertebral height restoration were evaluated. All occurring complications and injected cement volumes were recorded. The follow-up time was one year. Results: VAS and ODI scores improved in both groups, and did not differ significantly between the 2 groups. More cement was used in the BKP group than in HVCV group (4.22 vs. 3.31 mL, P < 0.0001). The incidence of cement leakage in the HVCV group was lower than that of the BKP group (13.24% vs 30.56%, P < 0.05). No symptomatic cement leakages occurred in the HVCV group. In the BKP group, one patient experienced discogenic back pain related to a disc leak, and another patient had asymptomatic cement emboli in the lung related to venous leakage. The mean compression rate before the procedure was 29.98% in the HVCV group and 28.67% in the BKP group (P = 0.94). The vertebral height was improved significantly and maintained at one-year follow-up in both groups. BKP was more effective in vertebral height restoration than HVCV (44.87% vs. 23.93%, P < 0.0001). There was one case of a new adjacent vertebral fracture in the HVCV group (2%), and 4 cases of new nonadjacent vertebral fractures in the BKP group (7.84%) (P = 0.18). Limitations: A single-center and relatively small-sample size study. Conclusion: HVCV and BKP are safe and effective in improving quality of life and relieving pain. HVCV has a lower cement leakage rate, whereas BKP is more effective in vertebral height restoration. Subsequent fractures are not different between the 2 groups. Key words: Vertebral compression fracture, spine, osteoporosis, cement augmentation, balloon kyphoplasty, vertebroplasty, cement leakage

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