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IRCT20210712051854N5 IRCT 2022-12-23 Tehran University of Medical Sciences Evaluation of patient specific implant outcomes in distal femoral osteotomy Evaluation of efficacy, safety and cost of using patient specific implants in distal femoral osteotomy in patients with cerebral palsy with Crouch gait compared to conventional method 2022-10-23 anticipated 20 Complete https://irct.ir/trial/66170 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block method was used for randomization. At first, blocks of 4 were defined using the randomization tool of the website https://www.sealedenvelope.com/simple-randomiser/v1/lists. Based on the placement order of groups A and B in each of these blocks, the order of the type of operation will be determined. Group A includes patients who will be treated with the old (conventional) method, and group B will be treated with the PSI method. The order of placement of patients in groups A and B in each of the blocks is determined based on the time of the patient's visit for surgery. For example, the first client is placed as person number one of block one in group A or B (determined by the software). The second client is placed as person number two of block one in group A or B (determined by the software). In this way, randomization will be done, Blinding description: All patients will be given complete information about the surgical procedure of each of the two groups, case and control. Also, patients will be informed about the possibility of being placed in any of these two groups. After that, based on random numbers, patients are placed in one of the two groups A and B. Patients will not know which group they are in, and thus they will enter the study blind. In this way, the relevant intervention will be carried out in a one-sided blind way on the two study groups. The treating doctor, surgeon and other medical personnel will be informed about the type of treatment if needed. But all the people involved in the surgical process, hospitalization and subsequent follow-up of patients will be justified not to provide information about the type of operation to the patient. It should be noted that the surgical scar of both operations is the same and it is not possible to know the type of operation from the appearance of the operation site. If necessary, the doctor can determine the type of plaque used and therefore the patient's operation group based on the graphs obtained from the patients after the operation. 1-2 crouch gait in cerebral palsy. Intervention 1: Intervention group number 1: 20 cerebral palsy patients with crouch gait. Plaque design: First, 3D images are prepared with the help of ct scan, and with the help of it, special plaques for each patient are designed virtually. Then the plaques that are designed virtually are used by the casting expert team to make patient-specific plaques (PSI). In the next step, PSI is tested in terms of quality and resistance and other necessary criteria. Finally, PSI is sterilized and packaged and used for use in surgery. Surgical technique: Distal femur extension osteotomy is performed using a lateral approach to the end of the femur behind the vastus lateralis. Also, the patellar tendon is separated from the tibia and passes under the periosteal flap. Surgery in both groups will be performed by the same surgeons and surgical team. Patients will be examined in terms of clinical parameters (including pain level, joint range of motion, and gait status), radiography, and walking 1, 3, and then every 6 months after surgery until 12 months after surgery. In order to perform these examinations, patients will visit the clinic at specified times, and clinical and graphic examinations will be taken from the patients at the surgery site. The data obtained from these actions will be recorded in SPSS 25.0 software for statistical analysis. Intervention 2: Intervention group number 2: 20 cerebral palsy patients with crouch gait. In this group, the common method of distal femur osteotomy and the use of angular blade plates will be used. These plates are designed with an angle of 90 degrees and after osteotomy, they fix the parts at the angle desired by the surgeon. 1, 3 and then every 6 months after surgery until 12 months after surgery will be checked. In order to perform these examinations, patients will visit the clinic at specified times, and clinical and graphic examinations will be taken from the patients at the surgery site. The data obtained from these actions will be recorded in SPSS 25.0 software for statistical analysis. Yes - There is a plan to make this available What will be shared: Information about the main outcome is shared When: After printing the results To whom: Researchers working in academic and scientific institutions Conditions: Ensure participants' privacy Data will be provided to academic researchers Where to obtain: e-mail How to obtain: After submitting the request, the reviews will be carried out within a week and if possible, the data will be provided to them. Comments:
public Mosayeb Soleymani
Jalal al ahmad
Tehran Iran (Islamic Republic of) 9561757393 +98 51 5422 8460 mosayeb_mst@yahoo.com Tehran University of Medical Sciences scientific Mohammadhosein Nabian
Jalal al ahmad
Tehran Iran (Islamic Republic of) 9561757393 +98 21 8490 1000 mosayeb_mst@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Documented diagnosis of CP spastic diplegic type severe crouch gait (dorsey ankle flexion > 15 degrees, knee bending > 30 degrees, and pelvic extension <3 degrees in late stand-up in sagittal plate kinematics data) Level I-III according to GMFCS classification Minimum function of 3D gait analysis before and after surgery in the three months before surgery and at least 2 years after surgery Age ≤ 18 at the time of surgery 4 years 18 years Both Patients with other motor disorders Any surgical prohibition (heart or respiratory problems) previous history of dorsal rhizotomy (Selective dorsal rhizotomy) botulinum toxin injection in the past 6 months or use of intraspinal baclofen pump G80.8 Other cerebral palsy Treatment - Devices Treatment - Devices Intervention group number 1: 20 cerebral palsy patients with crouch gait. Plaque design: First, 3D images are prepared with the help of ct scan, and with the help of it, special plaques for each patient are designed virtually. Then the plaques that are designed virtually are used by the casting expert team to make patient-specific plaques (PSI). In the next step, PSI is tested in terms of quality and resistance and other necessary criteria. Finally, PSI is sterilized and packaged and used for use in surgery. Surgical technique: Distal femur extension osteotomy is performed using a lateral approach to the end of the femur behind the vastus lateralis. Also, the patellar tendon is separated from the tibia and passes under the periosteal flap. Surgery in both groups will be performed by the same surgeons and surgical team. Patients will be examined in terms of clinical parameters (including pain level, joint range of motion, and gait status), radiography, and walking 1, 3, and then every 6 months after surgery until 12 months after surgery. In order to perform these examinations, patients will visit the clinic at specified times, and clinical and graphic examinations will be taken from the patients at the surgery site. The data obtained from these actions will be recorded in SPSS 25.0 software for statistical analysis. Intervention group number 2: 20 cerebral palsy patients with crouch gait. In this group, the common method of distal femur osteotomy and the use of angular blade plates will be used. These plates are designed with an angle of 90 degrees and after osteotomy, they fix the parts at the angle desired by the surgeon. 1, 3 and then every 6 months after surgery until 12 months after surgery will be checked. In order to perform these examinations, patients will visit the clinic at specified times, and clinical and graphic examinations will be taken from the patients at the surgery site. The data obtained from these actions will be recorded in SPSS 25.0 software for statistical analysis. Motor function collected by functional mobility scale questionnaire. Timepoint: 6 months and 1 year after surgery. Method of measurement: The child's motor ability and gait in three specified distances (5,50,500 meters) will be measured using functional mobility scale questionnaire. Tehran University of Medical Sciences Approved 2022-08-11 Research Ethics Committee of Medical School-Tehran University of Medical Sciences Islamic Revolution Street- University of Tehran Tehran Tehran Iran (Islamic Republic of)