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IRCT20230926059523N1 IRCT 2023-11-30 Shahid Beheshti University of Medical Sciences Bi unicondylar knee arthroplasty versus Total knee arthroplasty: A Randomized Clinical Trial Bi unicondylar knee arthroplasty versus Total knee arthroplasty: A Randomized Clinical Trial 2023-12-16 anticipated 26 Complete https://irct.ir/trial/72824 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients included in the study will be randomly divided into two groups, TKA and bi-uncondylar knee arthroplasty, using the block randomization method. First, the leg that has the most pain is subjected to TKA. The other category of foot that has the most pain is subjected to bi-UKA operation. Demographic, radiological, and laboratory characteristics will be compared between the two groups. After 1 month and 6 months from the last operation, the patient is followed up with frequent visits. And questionnaires related to patient function and pain will be filled for both legs. Then, a comparison will be made between the two groups as well as between the two models. N/A Knee osteoarthritis - knee joint replacement. Intervention 1: Intervention group: The leg that has the most pain is subjected to bi-UKA operation in such a way that the medial and lateral condyles of the knee are replaced with unicondylar prostheses and the anterior cruciate ligament is not damaged. (bi unicondylar knee arthroplasty) in this method. While preserving the cruciate ligament, only the medial and lateral condyles that are damaged in the arthritic process are replaced with medial and lateral unicondylar prostheses (an improved process for both condyles, compared to what is done in UKA), in order to establish proper alignment. joint, the process of replacing the joint with less damage to the healthy ligament structure (ACL) and with the aim of improving the performance of patients after surgery. Intervention 2: Control group:The leg that has the most pain is subjected to TKA. Yes - There is a plan to make this available What will be shared: Individual data of participants including radiological angles, scores of questionnaires When: The access period starts 1 year after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Determining a treatment plan and modeling to perform a similar action in patients who benefit more from bi-UKA Where to obtain: Contact by email alighaneitehrani@sbmu.ac.ir How to obtain: Sending an e-mail, introducing the organization or responsible person, expressing the work context and goals of accessing information and sending data within a period of 3-6 weeks Comments:
public ali ghanei tehrani
Shahid Madani Street, Tehran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 alighaneitehrani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific alighaneitehrani
Imam Hossein Square, Shahid Madani Street, Tehran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 alighaneitehrani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with medial and lateral OA suitable for treatment with standard unrestricted TKA Healthy cruciate ligaments (based on radiological evidence and clinical examination) Willing and able to provide informed consent 50 years no limit Both Patients with rheumatoid arthritis or other inflammatory arthropathy Varus or valgus deformity greater than 15 degrees Flexion contracture greater than 10 degrees Single-compartment OA suitable for isolated UKA Radiological evidence of Kelgren and Lawrence grade III OA of the patellar joint Patients who had undergone previous knee surgery that might affect the outcome of the arthroplasty, such as anterior or posterior cruciate ligament reconstruction Who had significant OA of the spine or other lower extremity joints were not included in the study Despite the diagnostic measures before the operation, if there is a clear ligament damage that makes the condition unfavorable for bi-uka surgery, the patient will be excluded from the study. M17.10 Unilateral primary osteoarthritis, unspecified knee Treatment - Surgery Treatment - Surgery Intervention group: The leg that has the most pain is subjected to bi-UKA operation in such a way that the medial and lateral condyles of the knee are replaced with unicondylar prostheses and the anterior cruciate ligament is not damaged. (bi unicondylar knee arthroplasty) in this method. While preserving the cruciate ligament, only the medial and lateral condyles that are damaged in the arthritic process are replaced with medial and lateral unicondylar prostheses (an improved process for both condyles, compared to what is done in UKA), in order to establish proper alignment. joint, the process of replacing the joint with less damage to the healthy ligament structure (ACL) and with the aim of improving the performance of patients after surgery. Control group:The leg that has the most pain is subjected to TKA KOOS (knee injury and osteoarthritis outcome) questionnaire score including daily activity, sports activity, pain, quality of life, symptoms and joint stiffness before and after surgery. Timepoint: After 1 month and 6 months from the last operation, the patient is followed up with frequent visits. And questionnaires related to patient function and pain will be filled for both legs. Method of measurement: Clinical records, pre- and post-surgery graphs,lab tests, questionnaires. Blood loss during and after surgery. Timepoint: Before, 1 day and 1 week after the operation. Method of measurement: Laboratory data. Duration of surgery. Timepoint: During the operation, from the time of skin incision to wound closure. Method of measurement: clock. Anatomical and mechanical angles and alignment of the knee joint. Timepoint: Before and after surgery. Method of measurement: standing 3-joint Aligment view graphs (hip-knee-ankle). Shahid Beheshti University of Medical Sciences Approved 2023-09-10 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Shahid Chamran Highway - Yemen St. - Shahid Abbas Arabi St. (Parvaneh) - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Health Care Services - Headquarters Building 2 - 5th Floor - Vice President of Research and Technology Tehran Tehran Iran (Islamic Republic of)