ObjectiveTo evaluate the safety of photoelectric guided navigation unilateral puncture of the percutaneous kyphoplasty (PKP) in the treatment of thoracolumbar osteoporotic vertebral compression fracture (OVCF).MethodsA randomized controlled clinical research was performed between June 2015 and January 2017. Eighty-five cases of OVCF were treated with photoelectric guided navigation unilateral puncture of the PKP (trial group, 43 cases) or C arm fluoroscopy unilateral puncture of the PKP (control group, 42 cases) respectively. There was no significant difference in gender, age, disease duration, segmental fracture, AO classification, bone mineral density, and preoperative visual analogue scale (VAS) score between 2 groups (P>0.05). The concordance rate of puncture path and design path, the incidence of pedicle wall breaking, the incidence of bone cement leakage, and the rate of bone cement distribution center were observed and calculated on postoperative CT images; the intraoperative X-ray exposure frequency, frequency of puncture, operation time, VAS scores before operation and at 2 days after operation, and postoperative blood vessel or nerve injury were recorded and compared.ResultsThe intraoperative X-ray exposure frequency and puncture frequency in trial group were significantly less than those in control group (P<0.05), but there was no significant difference in operation time between 2 groups (t=0.440, P=0.661). The VAS scores of 2 groups at 2 days after operation were significantly improved when compared with preoperative ones (P<0.05), but there was no significant difference in VAS score at 2 days after operation between 2 groups (t=0.406, P=0.685). All the patients were followed up 6-18 months (mean, 10 months). No blood vessel or nerve injury occurred in 2 groups. The incidence of pedicle wall breaking, the incidence of bone cement leakage, the concordance rate of puncture path and design path, and the rate of bone cement distribution center in trial group were 2.33% (1/43), 2.33% (1/43), 86.05% (37/43), and 88.37% (38/43) respectively, all showing significant differences when compared with those of control group [19.05% (8/42), 21.43% (9/42), 45.24% (19/42), and 50.00% (21/42) respectively] (P<0.05).ConclusionIntraoperative photoelectric guided navigation unilateral puncture of the PKP can improve the success rate of target puncture and reduce the incidence of pedicle wall breaking effectively, and achieve better bone cement distribution and better security.
ObjectiveTo compare the clinical efficacy and safety between percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral compression fracture (OVCF) with intravertebral vacuum cleft (IVC). MethodsBetween January 2010 and December 2013, 68 patients with single OVCF and IVC were treated, and the clinical data were retrospectively analyzed. Of 68 patients, 48 underwent PVP (PVP group) and 20 underwent PKP (PKP group). There was no significant difference in age, gender, disease duration, fracture level, bone mineral density (BMD), visual analogue scale (VAS), Oswestry disability index (ODI), and preoperative radiological parameters between 2 groups (P > 0.05). The intraoperative incidence of cement leakage, cement volume, and operative time were compared between 2 groups; VAS score was used for evaluation of back pain and ODI for evaluation of dysfunction; the incidence of adjacent vertebral fracture was observed within 2 years. The vertebral height and kyphotic angle were measured on X-ray films; the rate of vertebral compression (CR), reduction rate (RR), progressive height loss (PHL), reduction angle (RA), and progressive angle (PA) were calculated. ResultsThere was no significant difference in cement volume and the incidence of cement leakage between 2 groups (P > 0.05). The operative time in PVP group was shorter than that in PKP group, showing significant difference (t=-8.821, P=0.000). The mean follow-up time was 2.4 years (range, 2.0-3.1 years). The VAS scores and ODI were significantly reduced at 1 day, 1 year, and 2 years after operation when compared with preoperative scores (P < 0.05), but there was no significant difference between different time points after operation in 2 groups (P > 0.05). Adjacent vertebral fracture occurred in 5 cases (10.4%) of PVP group and in 2 cases (10.0%) of PKP group, showing no significant difference (χ2=0.003, P=0.963). BMD was significantly increased at 1 year and 2 years after operation when compared with preoperative BMD (P < 0.05), but no significant difference was found between 2 groups (t=0.463, P=0.642; t=0.465, P=0.646). The X-ray films showed that CR and kyphotic angle were significantly restored at immediate after operation in 2 groups (P < 0.05); but vertebral height and kyphotic angle gradually aggravated with time, showing significant difference between at immediate and at 1 and 2 years after operation (P < 0.05); there was no significant difference in CR and kyphotic angle between 2 groups at each time point (P > 0.05). RR, RA, PHL, and PA showed no significant difference between 2 groups (P > 0.05). ConclusionThere is similar clinical and radiological efficacy between PVP and PKP for treatment of OVCF with IVC. Re-collapse could happen after operation, so strict observation and follow-up are needed.
ObjectiveTo compare the effectiveness of robot assisted and C-arm assisted percutaneous kyphoplasty (PKP) in the treatment of single/double-segment osteoporotic vertebral compression fracture (OVCF).MethodsThe clinical data of 108 cases of single/double-segment OVCF who met the selection criteria between May 2018 and October 2019 were retrospectively analyzed. There were 65 cases of single-segment fractures, of which 38 cases underwent “TiRobot” orthopedic robot-assisted PKP (robot group), 27 cases underwent C-arm X-ray machine fluoroscopy-assisted PKP (C-arm group). There were 43 cases of double-segment fractures, including 21 cases in robot group and 22 cases in C-arm group. There was no significant difference in gender, age, T value of bone mineral density, fracture segment distribution, time from injury to operation, and preoperative visual analogue scale (VAS) score, vertebral kyphosis angle (VKA), and height of fractured vertebra (HFV) in the patients with single/double-segments fractures between robot group and C-arm group (P>0.05). The operation time, the fluoroscopy frequency of the surgeons and the patient, the fluoroscopy exposure time of the surgeons and the patient, the radiation dose of the C-arm; the VAS scores, VKA, HFV before operation, at 1 day and 6 months after operation; and the complications in the two groups were recorded and compared.ResultsAll patients underwent surgery successfully. The operation time of the single-segment robot group was significantly longer than that of the C-arm group (t=5.514, P=0.000), while the operation time of the double-segment robot group was not significantly different from that of the C-arm group (t=1.892, P=0.205). The single/double-segment robot group required three-dimensional scanning, so the fluoroscopy frequency, fluoroscopy exposure time, and radiation dose of C-arm received by the patient were significantly higher than those of the C-arm group (P<0.05); the fluoroscopy frequency and the fluoroscopy exposure time received by the surgeons were significantly less than those of the C-arm group (P<0.05). There was no infection, embolism, neurological injury, and adjacent segmental fractures. The single/double-segment robot group showed lower rate of cement leakage when compared with the C-arm group (P<0.05), all the cases of cement leakage happened outside the spinal canal. The VAS score, VKA, and HFV of the single/double-segment robot group and the C-arm group were significantly improved at 1 day and 6 months after operation (P<0.05), and the VAS score at 6 months after operation was further improved compared with that at 1 day after operation (P<0.05). At 1 day and 6 months after operation, there was no significant difference in VAS score between the single/double-segment robot group and the C-arm group (P>0.05). The VKA and HFV of robot group were significantly better than those of the C-arm group (P<0.05).ConclusionFor single/double-segment OVCF, robot assisted PKP has more advantages in correcting VKA and HFV, reducing fluoroscopy exposure of surgeons and bone cement leakage rate; C-arm assisted PKP has more advantages in reducing the operation time of single-segment OVCF and fluoroscopy exposure of patients during operation.
Objective To investigate the prel iminary effectiveness of percutaneous kyphoplasty (PKP) in treating vertebral compressive fractures in patients with osteoporosis. Methods Between February 2008 and June 2010, 31 cases (31vertebrae) of osteoporotic vertebral compressive fractures were treated with PKP. Of 31 cases, 10 were male and 21 were female, aged from 64 to 80 years (mean, 70.7 years). All fractures were caused by mild trauma with an disease duration of 1-13 days. Affected vertebrae included T12 in 8 cases, L1 in 9 cases, L2 in 12 cases, and L4 in 2 cases. The effectiveness was evaluated with visual analogue scale (VAS), the Cobb’s angle, and the anterior vertebral height. Results The operation was completed successfully in all cases, without serious postoperative complication. Cement leakage occurred in 11 cases (35.5%), including 3 cases at the anterior vertebral edge, 4 cases at the lateral vertebra, and 4 cases at the puncture tunnel. All the cases were followed up 6-15 months (mean, 11 months). The mean fracture healing time was 11.5 weeks (range, 8-12 weeks). VAS score was decreased from 8.1 ± 1.2 preoperatively to 2.5 ± 0.6 at 3 months postoperatively and to 2.3 ± 0.8 at last follow-up; the Cobb’s angle was improved from (30.2 ± 5.3)° to (21.3 ± 3.6)° and (23.5 ± 3.8)° respectively; and the anterior vertebral height was increased from (13.98 ± 4.62) mmto (22.03 ± 4.93) mm and (22.56 ± 4.34) mm respectively. There were significant differences in VAS, the Cobb’s angle, and the anterior vertebral height between pre- and post-operation (P lt; 0.05), but there was no significant difference between 3 months postoperatively and last follow-up (P gt; 0.05). Conclusion PKP is effective for osteoporotic vertebral compressive fractures, which can rel ieve pain effectively, correct kyphosis, and prevent collapse of vertebra.
ObjectiveTo compare the effect of percutaneous kyphoplasty (PKP) with different phases bone cement for treatment of osteoporotic vertebral compression fracture (OVCF).MethodsThe clinical data of 219 OVCF patients who treated with PKP and met the selection criteria between June 2016 and May 2018 were retrospectively analyzed. According to the different time of intraoperative injection of bone cement, they were divided into observation group [116 cases, intraoperative injection of polymethyl methacrylate (PMMA) bone cement in low-viscosity wet-sand phase)] and control group (103 cases, intraoperative injection of PMMA bone cement in low-viscosity wire-drawing phase). There was no significance in general date of gender, age, disease duration, body mass index, bone mineral density T value, fracture vertebral body, preoperative fracture severity of the responsible vertebral body, anterior height ratio of the responsible vertebral body, preoperative pain visual analogue scale (VAS) score, and Oswestry disability index (ODI) between the two groups (P>0.05). The VAS score and ODI score were used to evaluate the improvement of patients’ symptoms at immediate, 2 days, 3 months after operation and at last follow-up. At 1 day, 3 months after operation, and at last follow-up, X-ray film and CT of spine were reexamined to observe the distribution of bone cement in the vertebral body, bone cement leakage, and other complications. During the follow-up, the refracture rate of the responsible vertebral body and the fracture rate of the adjacent vertebral body were recorded.ResultsThe injection amount of bone cement in the observation group and control group were (4.53±0.45) mL and (4.49±0.57) mL, respectively, showing no significant difference between the two groups (t=1.018, P=0.310). Patients in both groups were followed up 6-18 months (mean, 13.3 months). There were 95 cases (81.9%) and 72 cases (69.9%) of the bone cement distribution range more than 49% of the cross-sectional area of the vertebral body in the observation group and the control group, respectively, showing significant difference in the incidence between the two groups (χ2=4.334, P=0.037). The VAS score and ODI score of the postoperative time points were significantly improved compared with those before operation (P<0.05), and there were significant differences among the postoperative time points (P<0.05). The VAS score and ODI score of the observation group were significantly better than those of the control group (P<0.05) at immediate, 2 days, and 3 months after operation, and there was no significant difference between the two groups at last follow-up (P>0.05). At 1 day after operation, the cement leakage occurred in 18 cases of the observation group (8 cases of venous leakage, 6 cases of paravertebral leakage, 4 cases of intradiscal leakage) and in 22 cases of the control group (9 cases of venous leakage, 8 cases of paravertebral leakage, 5 cases of intradiscal leakage). There was no significant difference between the two groups (P>0.05). During the follow-up, 5 cases (4.3%) in the observation group, 12 cases (11.7%) in the control group had responsible vertebral refracture, and 6 cases (5.2%) in the observation group and 14 cases (13.6%) in the control group had adjacent vertebral fracture, the differences were significant (χ2=4.105, P=0.043; χ2=4.661, P=0.031).ConclusionBone cement injection with wet-sand phase in PKP is beneficial for the bone cement evenly distributed, strengthening the responsible vertebral, relieving the short-term pain after operation, decreasing the rate of responsible vertebral refracture and adjacent vertebral fracture without increasing the incidence of relevant complications and can enhance the effectiveness.
Objective To observe the influence on adjacent lumbar bone density after strengthening of T12, L1 segment vertebral osteoporotic compression fracture by percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) in postmenopausal female. Methods Between January 2008 and June 2011, 59 patients with T12, L1 segment thoracolumbar osteoporotic compression fracture were treated with PVP in 29 cases (PVP group) and PKP in 30 cases (PKP group), who were in accordance with the inclusion and exclusion criteria. No significant difference was found in gender, duration of menopause, disease druation, causes of injury, fractured vertebral body, and vertebral fracture classification between 2 groups (P gt; 0.05). The kyphosis Cobb angle of surgical area was measured at preoperation, 1 week after operation, and last follow-up; the lower three lumbar spine bone mineral density (BMD) of the surgical area, the femoral neck BMD, and body mass index (BMI) of patients were measured at perioperative period and last follow-up to find out the statement of anti-osteoporosis; FRAX online tools were used to evaluate the probability of major osteoporotic fracture and hip fracture of the next 10 years. Results The average follow-up was 25.5 months (range, 12-48 months) in 2 groups. There was significant difference in kyphosis Cobb angle of T12, L1 between preoperation and last follow-up in 2 groups (P lt; 0.05); the Cobb angle of PKP group was significantly less than that of PVP group at 1 week after operation and last follow-up (P lt; 0.05). No significant difference was found in BMI between 2 groups, and between perioperative period and last follow-up in the same group (P gt; 0.05). The lower three lumbar spine BMD of the surgical area and its T value at last follow-up was improved significantly when compared with BMD at perioperative period (P lt; 0.05); there was no significant difference in the lower three lumbar spine BMD and its T value between 2 groups at perioperative period (P gt; 0.05), but significant difference was found between two groups at last follow-up (P lt; 0.05). Difference was not significant in the femoral neck BMD and its T value between 2 groups, and between perioperative period and last follow-up in the same group (P gt; 0.05). The probability of major osteoporotic fracture and hip fracture of the next 10 years was not significantly different between 2 groups and between perioperative period and last follow-up in the same group (P gt; 0.05). Conclusion The increased BMD of adjacent lumbar spine can improve the strength of the vertebral body and reduce the incidence of adjacent vertebral fracture in patients with T12, L1 segment vertebral osteoporotic compression fracture after PVP/PKP, and PKP is superior to PVP increasing BMD of adjacent lumbar spine.
Objective To investigate the efficiency of manual reduction combined with uni-lateral percutaneous kyphoplasty (PKP) in treating osteoporotic vertebral compression fracture (OVCF). Methods Between May 2005 and May 2009, the manual reduction combined with uni-lateral PKP was appl ied to treat 42 patients with OVCF (group A), and the simple uni-lateral PKP was appl ied to treat 43 patients with OVCF (group B) at the same period. The visual analogue scale (VAS), the vertebral height, and the Cobb angle were determined before operation, and at 3 days and 6 months after operation. Ingroup A, there were 6 males and 36 females aged 59-93 years (76.5 years on average) with an average disease duration of 7 days (range, 3 hours to 21 days); 27 segments of thoracic vertebrae and 31 segments of lumbar vertebrae were involved, including 15 segments at mild degree, 38 segments at moderate degree, and 5 segments at severe degree according to degree classification system of compression fractures of Zoarski and Peh. In group B, there were 9 males and 34 females aged 54-82 years (75.3 years on average) with an average disease duration of 7 days (range, 1 hour to 20 days); 26 segments of thoracic vertebrae and 35 segments of lumbar vertebrae were involved, including 21 segments at mild degree, 36 segments at moderate degree, and 4 segments at severe degree according to degree classification system of compression fractures of Zoarski and Peh. There were no significant difference (P gt; 0.05) in sex, age, affected site, degree, and disease duration between 2 groups. Results There was no significant difference (P gt; 0.05) in operative time, blood loss, or injected cement volume between 2 groups. No serious compl ication or death occurred in 2 groups. Cement leakage was observed in 4 cases (9.5%) of group A and in 5 cases (11.6%) of group B. The VAS scores after operation significantly decreased in 2 groups (P lt; 0.01). At 3 days and 6 months after operation, the VAS scores in group A were significantly lower than those in group B (P lt; 0.05). The postoperative compression rates of affected vertebral body in 2 groups significantly decreased (P lt; 0.01). The compression rates of affected vertebral body at 3 days and 6 months after operation, and the height recovery rate at 3 days after operation in group A were superior to those in groupB (P lt; 0.05). The postoperative Cobb angles in 2 groups were significantly diminished (P lt; 0.01). The Cobb angles at 3 days and 6 months after operation, and the recovery rate at 3 days after operation in group A were superior to those in group B (P lt; 0.05). Conclusion The cl inical efficiency of the manual reduction combined with uni-lateral PKP is superior to that of simple uni-lateral PKP in treatment of severe OVCF.
Objective To manage the preoperative, intraoperative and postoperative pain of percutaneous kyphoplasty (PKP) under the concept of enhanced recovery after surgery (ERAS) and explore the role of pain management under the ERAS concept in enhancing postoperative rehabilitation of PKP. Methods From January to December 2016, 136 patients with osteoporotic compression fractures treated with PKP of local anesthesia were selected, among which 71 patients in the ERAS group were treated between July and December 2016, who were treated with celecoxib capsule for analgesia before the operation and such local anesthetics as lidocaine and ropivacaine combined with intravenous injection of dexmedetomidine hydrochloride for multi-mode analgesia during the operation; after the operation, celecoxib capsules and tizanidine hydrochloride tablets were orally administered by the routine for analgesia; if the pain was increased, 40 mg parecoxib would be added for analgesia by intramuscular injection. While 65 patients in the conventional group were treated between January and June 2016, who were given intraoperative local anesthesia with lidocaine; if the patients suffered from severe pain after the operation, they would be given 40 mg parecoxib by intramuscular injection. The Visual Analogue Scale (VAS), mean arterial pressure (MAP), the complications after surgery, postoperative infections, bed rest time, length of hospital stay and patient satisfaction were compared between the two groups. Results There was no statistical difference in age, gender or fracture vertebral number between the two groups (P>0.05). The preoperative, intraoperative and postoperative VAS scores (4.0±1.5, 4.8±1.8, 1.6±1.1), MAP change [(22.0±4.7) mm Hg (1 mm Hg=0.133 kPa)], bed rest time [(1.5±0.7) days], and length of hospital stay [(3.8±0.8) days] in the ERAS group were significantly less than those in the conventional group [4.7±1.7, 5.7±1.5, 2.4±1.1, (31.3±6.1) mm Hg, (2.1±0.8) days, and (5.0±1.6) days, respectively] (P<0.05). The incidence of intraoperative complication of bone cement leakage (4.2%, 3/71) in the ERAS group was lower than that in the conventional group (13.8%, 9/65) (P<0.05); there was no statistical difference in postoperative pulmonary infection between the two groups (P>0.05). Patients’ satisfaction was significantly improved from 86.2% (the conventional group) to 95.8% (the ERAS group) (P<0.05). There was no incision infection, urinary tract infection or venous thrombosis in the two groups. Conclusion With the concept of ERAS, taking a management of pain can effectively alleviate the dis-comfortable pain feeling, improve the patients’ satisfaction, and enhance the recovery for the patients after PKP surgery.
Objective To explore the clinical efficacy and safety of percutaneous kyphoplasty (PKP) in the treatment of Kummell disease. Methods We retrospectively analyzed the clinical data of 11 patients with Kummell disease treated by PKP between January 2013 and January 2016. There were 8 males and 3 females with an average age of 72.3 years old ranging from 64 to 78. The injured vertebra was located at T11 in 2 patients, T12 in 3, and L1 in 6. All the patients suffered from lower back pain for 2.5-15.0 months averaging 7.6 months. Preoperative CT and MRI examinations showed that there were clear signs of intravertebral vacuum cleft and abnormal fluid signals. The Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and the height and kyphotic angle of the injured vertebral body were measured to evaluate the clinical outcomes before and after surgery. Results Follow-up was conducted for all 11 patients. Cement leakage occurred in 4 patients with no symptoms. The vertebral height, Cobb angel of the injured vertebra, VAS and ODI improved significantly after surgery and during the latest follow-up. Compared with those parameters after surgery, only VAS score was different during the latest follow-up. Conclusion PKP is safe and effective in the treatment of Kummell disease.
ObjectiveTo investigate the effectiveness of synchronous unilateral percutaneous kyphoplasty (PKP) in the treatment of double noncontiguous thoracolumbar osteoporotic vertebral compression fracture (OVCF). MethodsBetween December 2018 and September 2020, 27 patients with double noncontiguous thoracolumbar OVCF were treated by synchronous unilateral PKP. There were 11 males and 16 females, with an average age of 75.4 years (range, 66-92 years). The fractures were caused by falls in 22 cases and sprains in 5 cases. The time from injury to hospital admission was 0.5-7.0 days, with an average of 2.1 days. The fractured vertebrae located at T9 in 2 cases, T10 in 3 cases, T11 in 10 cases, T12 in 15 cases, L1 in 12 cases, L2 in 6 cases, L3 in 4 cases, and L4 in 2 cases. The volume of bone cement injected into each vertebral body, operation time, and intraoperative fluoroscopy times were recorded. Anteroposterior and lateral X-ray films of thoracolumbar spine were taken to observe the anterior height of the injured vertebra, the Cobb angle of kyphosis, and the diffusion and good distribution rate of bone cement in the thoracolumbar spine. Visual analogue scale (VAS) score and Oswestry disability index (ODI) were used to evaluate the pain and functional improvement. ResultsAll operations completed successfully. The operation time was 34-70 minutes, with an average of 45.4 minutes. The intraoperative fluoroscopy was 21- 60 times, with an average of 38.6 times. The volume of bone cement injected into each vertebral body was 2-9 mL, with an average of 4.3 mL. All patients were followed up 6-21 months, with an average of 11.3 months. X-ray film reexamination showed that the anterior height of the injured vertebra and Cobb angle at each time point after operation were significantly improved than those before operation (P<0.05), and there was no significant difference between different time points after operation (P>0.05). The distribution of bone cement was excellent in 40 vertebral bodies, good in 13 vertebral bodies, and poor in 1 vertebral body, and the excellent and good rate was 98.1% (53/54). The pain of all patients significantly relieved or disappeared, and the function improved. The VAS score and ODI at each time point after operation were significantly lower than those before operation (P<0.05), and there was no significant difference between different time points after operation (P>0.05).ConclusionFor the double noncontiguous thoracolumbar OVCF, the synchronous unilateral PKP has the advantages of simple puncture, less trauma, less intraoperative fluoroscopy, shorter operation time, satisfactory distribution of bone cement, etc. It can restore the height of the vertebral body, correct the kyphotic angle, significantly alleviate the pain, and improve the function.