Comparison of amount of bone cement penetration and short-term outcomes in total knee arthroplasty with and without the use of tourniquets

Determining the average amount of bleeding, the amount of pain, the strength of knee extension and flexion, the number of changes in body size, and the incidence of complications after the operation, comparing the amount of knee ROM changes in total knee arthroplasty in two methods with and without the use of a tourniquet. Comparison of the amount of cement penetration in total knee arthroplasty in two methods with and without Using a tourniquet Investigating the relationship between BMD score and cement penetration rate in patients undergoing total knee joint surgery

A clinical trial with a control group, with a parallel-group, double-blind, on 60 patients who are randomized by randomization.com

The study is conducted on patients referred to the Imam Khomeini Orthopedic Clinic in Tehran who are candidates for TKA. The surgeon, the patients, and the data analyst are blinded, which is done by the secretary of the blinding and randomization of the patients.

Inclusion criteria Diagnosis and confirmation of indications for TKA Age 55 to 85 years BMI below 45 kg/m2 Kellgren & Lawrence osteoarthritis with score III ASA score I or II NexGen Zimmer Biomet and DePuy implants exclusion criteria History of previous knee fracture or surgery malignancy Rheumatoid disease Cardiovascular disease infectious disease Neurological disorder Liver failure DVT/PTE/Glucocorticoid,heparin,warfarin/neuromuscular disease

The first group includes patients who undergo surgery with the use of a tourniquet, and the second group includes patients who undergo surgery without the use of a tourniquet.

The results of the study include reduction of pain, bleeding, postoperative complications, increase of muscle strength, increase of knee ROM, increase of cement penetration after TKA operation.

Randomization by the method of 2 blocks and individually by the site randomization.com, done by a person outside the study and informed to the operating room personnel without the surgeon's knowledge.

Randomization is done by a third person outside the study, and on the day of the surgery, another person outside the surgery, who is from the operating room staff, is informed, and the data is performed by another third party. It is collected without the knowledge of the surgeon. Data analysis is done by another person who is outside the study in 2 separate groups without knowing the type of intervention. At the beginning of the study, the type of intervention was explained to all patients, and consent was obtained, but the patient was unaware of the type of randomization.

After de-identifying people, the entire data can be shared and published as a file

The access period starts 9 months after the results are published

People working in academic and scientific centers will have access to the file

The data are for designing future studies and are allowed to be used

hesan rezaee 00989128651586 hesan.rezaee@gmail.com

Along with the request, a summary of the academic and professional degree and the university center where the student is employed should be sent. The data file will be sent within 2 weeks at most.