Weifeng Liao1, Xinning He1, Zhiyong Du1, Yi Long2. 1. Department of Spine Surgery, the Orthopedics Hospital of Traditional Chinese Medicine Zhuzhou City. 2. Department of Joint Surgery, the Affiliated Zhuzhou Hospital Xiangya Medical College CSU, Zhuzhou, Hunan, China.
Abstract
BACKGROUND: In the past few decades, the number of surgery of anterior cruciate ligament reconstruction (ACLR) implemented in the outpatient centers has dramatically enhanced. There is still a lack of effective randomized controlled trials in the literature to demonstrate the effectiveness of tourniquets. As a kind of prospective clinical trial, this research protocol is conducted to compare the results of ACLR with and without the use of a tourniquet. METHODS: All the patients aged 18 or over who underwent the selective primary anterior cruciate ligament reconstruction in our hospital from November 2020 to January 2022 are eligible to take part in our experiment. Exclusion criteria are history of peripheral neuropathy, pregnancy, lumbar radiculopathy, or surgery to the injured or contralateral knee. After the written informed consent is given, the patients participating in the study are randomly assigned to the tourniquet group (group 1) and the tourniquet free group (group 2) on the day of operation, through utilizing the computer-generated random table with 10 members in each group. And the assignments were kept in an opaque and sealed envelope. Any comments on visual difficulties in the process of operative time, arthroscopy, complications, and total bleeding from suction and drainage, as well as the reduction of postoperative hemoglobin are assessed as the parameters. The software of SPSS v. 24 is applied for all the statistical analyses. RESULTS: This protocol will provide a reliable theoretical basis for the following research. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6240).
BACKGROUND: In the past few decades, the number of surgery of anterior cruciate ligament reconstruction (ACLR) implemented in the outpatient centers has dramatically enhanced. There is still a lack of effective randomized controlled trials in the literature to demonstrate the effectiveness of tourniquets. As a kind of prospective clinical trial, this research protocol is conducted to compare the results of ACLR with and without the use of a tourniquet. METHODS: All the patients aged 18 or over who underwent the selective primary anterior cruciate ligament reconstruction in our hospital from November 2020 to January 2022 are eligible to take part in our experiment. Exclusion criteria are history of peripheral neuropathy, pregnancy, lumbar radiculopathy, or surgery to the injured or contralateral knee. After the written informed consent is given, the patients participating in the study are randomly assigned to the tourniquet group (group 1) and the tourniquet free group (group 2) on the day of operation, through utilizing the computer-generated random table with 10 members in each group. And the assignments were kept in an opaque and sealed envelope. Any comments on visual difficulties in the process of operative time, arthroscopy, complications, and total bleeding from suction and drainage, as well as the reduction of postoperative hemoglobin are assessed as the parameters. The software of SPSS v. 24 is applied for all the statistical analyses. RESULTS: This protocol will provide a reliable theoretical basis for the following research. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6240).