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IRCT20200325046855N1 IRCT 2020-04-11 National Natural Science Foundation of China Effect of percutaneous vertebroplasty vs. kyphoplasty in treatment of Kümmell’s disease Percutaneous Vertebroplasty Trial Comparison of the clinical outcomes of percutaneous vertebroplasty vs. kyphoplasty for the treatment of osteoporotic Kümmell’s disease 2637-02-20 anticipated 60 Pending https://irct.ir/trial/46874 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: Method of randomization： Simple randomization. Unit of randomization : individual. Tools used in randomization : table of random numbers. We set up a random sequence from a random number table. No undistributed concealment was made, Blinding description: Patients were blinded. The patient only knew that the operation was vertebroplasty, but did not know that it was PVP or PKP surgery. Therefore, patients did not know the specific grouping. Patients, principle investigator, healthcare providers, data safety and monitoring board and nurses didn't know exactly what kind of intervention was done. Physicians, investigators, data collectors,and outcome assessor knew about the subgroups. 4 Kümmell’s disease is a special type of osteoporotic vertebral compression fracture (OVCF), which is relatively rare in clinical practice. Kümmell's disease is also known as nonunion after OVCF, delayed vertebral osteonecrosis after trauma, and delayed vertebral collapse. Imaging examination can discover the late-onset collapse of vertebrae and characteristic change of intravertebral vacuum cleft (IVC), which is considered one of important inducing factors for injured vertebral progress after the collapse, deformity of kyphosis, intractable back pain and spinal cord damage after OVCF.. Intervention 1: Intervention group: PVP group of surgeries were performed by the same group of physicians, and the PVP procedures followed the same principle. The patients were placed in the prone position to maintain the spine's posterior extension for position reduction. Bilateral pedicle puncture with local anesthesia guided by C-arm X-ray machine. The working sleeve reached the IVC area in the anterior 1/3 of the vertebra or close to the IVC area. Polymethylmethacrylate (Tecres SPA, Verona, Italy) was injected into the IVC region using a 3.5mm side opening bone cement injector (Shanghai Kinetic Medical Co., Ltd., Shanghai, China) until the entire crack was fully filled and the cement was well dispersed. Finally, the bone cement was injected into the IVC region through the side opening injector until the entire fracture was filled. Intervention 2: Control group: PKP group of surgeries were performed by the same group of physicians, and the PKP procedures followed the same principle. The patients were placed in the prone position to maintain the spine's posterior extension for position reduction. Bilateral pedicle puncture with local anesthesia guided by C-arm X-ray machine. The working sleeve reached the IVC area in the anterior 1/3 of the vertebra or close to the IVC area. Polymethylmethacrylate (Tecres SPA, Verona, Italy) was injected into the IVC region using a 3.5mm side opening bone cement injector (Shanghai Kinetic Medical Co., Ltd., Shanghai, China) until the entire crack was fully filled and the cement was well dispersed. After the working sleeve reached the IVC area, the extended balloon catheter (Shanghai Kinetic Medical Co., Ltd., Shanghai, China) was first delivered to the IVC area through the work channel. The balloon was expanded, and the pressure of the balloon system was controlled within 15 atmospheres to make the satisfactory reduction of the fractures around the IVC area and the corresponding endplate. Finally, the bone cement was injected into the IVC region through the side opening injector until the entire fracture was filled. Yes - There is a plan to make this available What will be shared: Comparison of the clinical outcomes of percutaneous vertebroplasty vs. kyphoplasty for the treatment of osteoporotic Kümmell’s disease When: starting 6 months after publication. To whom: only available for people working in academic institutions or people working in businesses can also apply to receive it. Conditions: Information about who will review requests and criteria for reviewing requests may also be provided. Where to obtain: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. How to obtain: send information of these documents /data files via email or share it on a website. Comments: no
public Cheng-Liang Wang
209
Wuhan China 430080 +86 27 8648 7273 13476174874@139.com CR & WISCO General Hospital scientific Chang-Jian Zhong
209
Wuhan China 430080 +86 27 8648 7273 389391046@qq.com CR & WISCO General Hospital China Patients suffered single-segment Kümmell's disease without new OVCF in the adjacent vertebrae; Computed tomography (CT) or magnetic resonance imaging (MRI) examination confirmed the existence of IVC. the IVC refers to a significant radiolucency (gas containing), which is located centrally or adjacent to the vertebral body endplates as seen on CT or plain radiographs. On MRI, it is usually shown as a low signal intensity on a T1-weighted image and as a high signal or a low signal on a T2-weighted image, depending on whether the fluid or gas fills the cleft; Dual energy X-ray measurement of bone mineral density (BMD) T value was less than -2.5; PVP or PKP was conducted with bilateral pedicle; Follow-up time was more than 2 years； Postoperative calcium supplementation and anti-osteoporotic drugs were applied; No fall or other trauma occurred. 55 years 90 years Both Patients with severe cardiopulmonary dysfunction; Patients with coagulopathy; Patients with local or systemic infection; Patients with nerve root or spinal cord compression symptoms; Patients with pathological fractures other than osteoporosis. D49.2 Neoplasm of unspecified behavior of bone, soft tissue, and skin Treatment - Surgery Treatment - Other Intervention group: PVP group of surgeries were performed by the same group of physicians, and the PVP procedures followed the same principle. The patients were placed in the prone position to maintain the spine's posterior extension for position reduction. Bilateral pedicle puncture with local anesthesia guided by C-arm X-ray machine. The working sleeve reached the IVC area in the anterior 1/3 of the vertebra or close to the IVC area. Polymethylmethacrylate (Tecres SPA, Verona, Italy) was injected into the IVC region using a 3.5mm side opening bone cement injector (Shanghai Kinetic Medical Co., Ltd., Shanghai, China) until the entire crack was fully filled and the cement was well dispersed. Finally, the bone cement was injected into the IVC region through the side opening injector until the entire fracture was filled. Control group: PKP group of surgeries were performed by the same group of physicians, and the PKP procedures followed the same principle. The patients were placed in the prone position to maintain the spine's posterior extension for position reduction. Bilateral pedicle puncture with local anesthesia guided by C-arm X-ray machine. The working sleeve reached the IVC area in the anterior 1/3 of the vertebra or close to the IVC area. Polymethylmethacrylate (Tecres SPA, Verona, Italy) was injected into the IVC region using a 3.5mm side opening bone cement injector (Shanghai Kinetic Medical Co., Ltd., Shanghai, China) until the entire crack was fully filled and the cement was well dispersed. After the working sleeve reached the IVC area, the extended balloon catheter (Shanghai Kinetic Medical Co., Ltd., Shanghai, China) was first delivered to the IVC area through the work channel. The balloon was expanded, and the pressure of the balloon system was controlled within 15 atmospheres to make the satisfactory reduction of the fractures around the IVC area and the corresponding endplate. Finally, the bone cement was injected into the IVC region through the side opening injector until the entire fracture was filled. The Oswestry disability index (ODI). Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: The ODI scale was used to evaluate the severity of the dysfunction [9]. Visual analogue scale (VAS). Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: VAS is measured according to visual analogue scale. Bone cement leakage rate. Timepoint: After surgery. Method of measurement: X-ray film is used to observe whether there is leakage of bone cement. The incidence of new adjacent vertebral fracture. Timepoint: at 1 days, 1 year and 2 years after surgery. Method of measurement: X-ray film is used to observe whether there is a new adjacent vertebral fracture. Rate of vertebral compression. Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: Imaging measurement indexes: the height of the injured vertebral body and the kyphosis angle were measured before and after the operation by the anteroposterior and lateral X-ray images[10]. And the following indexes were calculated. 1) Rate of vertebral compression = the height of the injured vertebral body / the average height of adjacent upper and lower vertebral body heights [10];. Correction degree of kyphosis. Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: Imaging measurement indexes: the height of the injured vertebral body and the kyphosis angle were measured before and after the operation by the anteroposterior and lateral X-ray images[10]. And the following indexes were calculated. Correction degree of kyphosis = (preoperative kyphosis angle - postoperative kyphosis angle) / preoperative kyphosis angle × % [11]. Complications of bone cement. Timepoint: intraoperation and postoperation. Method of measurement: Closely observe the patient's symptoms and consult chief complaint and conduct related clinical examination。. National Natural Science Foundation of China Approved 2637-01-15 Ethics Committees of CR & WISCO General Hospital 209 Wuhan Hubei Province China