A novel "three-dimensional-printed individual guide template-assisted percutaneous vertebroplasty" for osteoporotic vertebral compression fracture: a prospective, controlled study
Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluorosc...
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| Published in | Journal of orthopaedic surgery and research Vol. 16; no. 1; p. 326 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
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England
BioMed Central Ltd
20.05.2021
BioMed Central BMC |
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| Abstract | Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by "three-dimensional printed individual guide template" versus conventional PVP.
Patients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures.
A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05).
Compared with the conventional PVP, "three-dimensional-printed individual guide template-assisted PVP" could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method.
The present study was registered with the Chinese Clinical Trial Registry (ChiCTR) ( http://www.chictr.org.cn ), and its registration no. is ChiCTR1900024283. |
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| AbstractList | Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by “three-dimensional printed individual guide template” versus conventional PVP. Method Patients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures. Results A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05). Conclusions Compared with the conventional PVP, “three-dimensional-printed individual guide template-assisted PVP” could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. Trial registration The present study was registered with the Chinese Clinical Trial Registry (ChiCTR) (http://www.chictr.org.cn), and its registration no. is ChiCTR1900024283. Abstract Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by “three-dimensional printed individual guide template” versus conventional PVP. Method Patients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures. Results A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) ( P > 0.05). Conclusions Compared with the conventional PVP, “three-dimensional-printed individual guide template-assisted PVP” could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. Trial registration The present study was registered with the Chinese Clinical Trial Registry (ChiCTR) ( http://www.chictr.org.cn ), and its registration no. is ChiCTR1900024283. Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by "three-dimensional printed individual guide template" versus conventional PVP. Patients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures. A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05). Compared with the conventional PVP, "three-dimensional-printed individual guide template-assisted PVP" could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. The present study was registered with the Chinese Clinical Trial Registry (ChiCTR) ( http://www.chictr.org.cn ), and its registration no. is ChiCTR1900024283. Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by "three-dimensional printed individual guide template" versus conventional PVP. Method Patients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures. Results A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 [+ or -] 0.8 in group A vs 5.2 [+ or -] 1.9 in group B, P < 0.05), TRD (4.9 [+ or -] 0.9 mGy vs 7.9 [+ or -] 1.6 mGy, P < 0.05), TFT (16.7 [+ or -] 2.9 vs 26.6 [+ or -] 5.3, P < 0.05), and total operation time (19.4 [+ or -] 2.4 min vs 27.8 [+ or -] 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05). Conclusions Compared with the conventional PVP, "three-dimensional-printed individual guide template-assisted PVP" could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. Trial registration The present study was registered with the Chinese Clinical Trial Registry (ChiCTR) ( Keywords: Osteoporotic vertebral compression fractures, Percutaneous vertebroplasty, Materialise Interactive Medical Image Control System, Three-dimensional printing technology, Navigation template BACKGROUNDConventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by "three-dimensional printed individual guide template" versus conventional PVP. METHODPatients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures. RESULTSA total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05). CONCLUSIONSCompared with the conventional PVP, "three-dimensional-printed individual guide template-assisted PVP" could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. TRIAL REGISTRATIONThe present study was registered with the Chinese Clinical Trial Registry (ChiCTR) ( http://www.chictr.org.cn ), and its registration no. is ChiCTR1900024283. Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by "three-dimensional printed individual guide template" versus conventional PVP. A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 [+ or -] 0.8 in group A vs 5.2 [+ or -] 1.9 in group B, P < 0.05), TRD (4.9 [+ or -] 0.9 mGy vs 7.9 [+ or -] 1.6 mGy, P < 0.05), TFT (16.7 [+ or -] 2.9 vs 26.6 [+ or -] 5.3, P < 0.05), and total operation time (19.4 [+ or -] 2.4 min vs 27.8 [+ or -] 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05). Compared with the conventional PVP, "three-dimensional-printed individual guide template-assisted PVP" could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. Abstract Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by “three-dimensional printed individual guide template” versus conventional PVP. Method Patients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures. Results A total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05). Conclusions Compared with the conventional PVP, “three-dimensional-printed individual guide template-assisted PVP” could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method. Trial registration The present study was registered with the Chinese Clinical Trial Registry (ChiCTR) ( http://www.chictr.org.cn ), and its registration no. is ChiCTR1900024283. |
| ArticleNumber | 326 |
| Audience | Academic |
| Author | Su, Nan Lin, Ji Sheng Meng, Hai Hu, Pei Lun Yang, Yong Fei, Qi |
| Author_xml | – sequence: 1 givenname: Pei Lun surname: Hu fullname: Hu, Pei Lun organization: Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, People's Republic of China – sequence: 2 givenname: Ji Sheng surname: Lin fullname: Lin, Ji Sheng organization: Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, People's Republic of China – sequence: 3 givenname: Hai surname: Meng fullname: Meng, Hai organization: Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, People's Republic of China – sequence: 4 givenname: Nan surname: Su fullname: Su, Nan organization: Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, People's Republic of China – sequence: 5 givenname: Yong surname: Yang fullname: Yang, Yong organization: Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, People's Republic of China – sequence: 6 givenname: Qi orcidid: 0000-0001-9753-2692 surname: Fei fullname: Fei, Qi email: spinefei@126.com organization: Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, People's Republic of China. spinefei@126.com |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34016139$$D View this record in MEDLINE/PubMed |
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| Keywords | Navigation template Materialise Interactive Medical Image Control System Osteoporotic vertebral compression fractures Percutaneous vertebroplasty Three-dimensional printing technology |
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| References | P Zheng (2471_CR28) 2017; 12 J Li (2471_CR7) 2008; 52 R Hasserius (2471_CR4) 2005; 76 P Hu (2471_CR8) 2019; 152 GS Sidhu (2471_CR17) 2013; 19 NT Fitousi (2471_CR12) 2006; 31 EZ Yang (2471_CR9) 2016; 41 2471_CR19 RS Zhu (2471_CR25) 2019; 30 J Xu (2471_CR21) 2019; 26 GC Anselmetti (2471_CR6) 2011; 22 F Tome-Bermejo (2471_CR16) 2013; 39 A Saracen (2471_CR18) 2016; 95 AJ Ringer (2471_CR20) 2013; 80 Orthopaedic Society of the Chinese Medical Association (2471_CR22) 2017; 37 RN Joseph (2471_CR11) 2013; 27 CE Firanescu (2471_CR23) 2018; 361 Y Zhang (2471_CR27) 2018; 97 G Corcos (2471_CR15) 2014; 39 H Prather (2471_CR3) 2007; 38 R Harstall (2471_CR13) 2005; 30 H Balkarli (2471_CR14) 2015; 8 G Ballane (2471_CR2) 2017; 28 D Andrei (2471_CR24) 2017; 41 2471_CR5 YH Jun (2471_CR10) 2016; 19 C Shen (2471_CR26) 2015; 38 O Johnell (2471_CR1) 2006; 17 |
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| Snippet | Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients,... Abstract Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation... Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to... BACKGROUNDConventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to... Abstract Background Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation... |
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| SubjectTerms | 3-D printers 3D printing Back pain Bone surgery Compression Control systems Dosage Fluoroscopy Fractures Local anesthesia Materialise Interactive Medical Image Control System Medical imaging equipment Medical research Medicine, Experimental Navigation template Orthopedic surgery Orthopedics Osteoporosis Osteoporotic vertebral compression fractures Patients Percutaneous vertebroplasty Povidone Radiation Skin Software Surgeons Surgery Three-dimensional printing technology Vertebrae X-rays |
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| Title | A novel "three-dimensional-printed individual guide template-assisted percutaneous vertebroplasty" for osteoporotic vertebral compression fracture: a prospective, controlled study |
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