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
The main objectives:
Comparison of efficacy, safety and cost of using patient specific implants in distal femoral osteotomy in patients with cerebral palsy (Crouch gait) with conventional method in these patients
Practical aim:
Widespread use of patient specific implants in patients with cerebral palsy
Design
The clinical trial has a control group with parallel, one-blind, randomized, phase 1-2 groups on 20 patients with crouch gait. Random numbers used for randomization.
Settings and conduct
This study is a clinical trial study on cerebral palsy patients with crotchgate referred to Shariati Hospital.
In order to design the implant, patients in the intervention group will undergo CT Scan scan. With the help of CT Scan images and computer software design, PSI and 3D design, surgical procedures will be performed.
In control group, radiologic images will be taken to determine the location of osteotomy and planning for operation. Then, lateral operoch will be performed from the posterior muscle of the osteomy letral lastosis and angled blade plaque will be placed in place.
After surgery, patients will be followed for 1 year. During this period, radiographic gait analysis, physical examinations, functional tests and postoperative complications will be evaluated. Cases such as duration of surgery and bleeding during surgery will also be evaluated in two groups. The final cost of surgery will be evaluated in two groups.
Participants/Inclusion and exclusion criteria
Documented diagnosis of CP spastic diplegic type
Extreme curved walking
Level I-III according to GMFCS
Age ≤ 18 at the time of surgery
Intervention groups
40 CP patients with
20 are in group A, who treated by conventional method. 20 are in group B, who treated by PSI.
Main outcome variables
Knee pain
Stiff knee
Damage to nerves and vessels
Motor function
Quality of Life
Not boiling bones
Angularity of bone alignment
Gate Analysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051854N5
Registration date:2022-12-23, 1401/10/02
Registration timing:registered_while_recruiting
Last update:2022-12-23, 1401/10/02
Update count:0
Registration date
2022-12-23, 1401/10/02
Registrant information
Name
Mohammad Hossein Nabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 1444
Email address
dr.nabian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of patient specific implant outcomes in distal femoral osteotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 4 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Medical School-Tehran University of Medical Sciences
Street address
Islamic Revolution Street- University of Tehran
City
Tehran
Province
Tehran
Postal code
9561757393
Approval date
2022-08-11, 1401/05/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.316
Health conditions studied
1
Description of health condition studied
crouch gait in cerebral palsy
ICD-10 code
G80.8
ICD-10 code description
Other cerebral palsy
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.