2.3. The Clinical Part of the Research
rheumatoid, injuries, patellar, knee rupture
DEGENERATIVE, SURGICAL COMPLICATIONS, RECRUITMENT
The second part of the research consisted of a prospective randomized clinical trial conducted at the Clinic for Orthopedic Surgery and Traumatology of the Clinical Center of Vojvodina in Novi Sad after receiving approval from the Ethics Committee of the University Clinical Center of Vojvodina. The study involved 120 patients who underwent operative reconstruction of the anterior cruciate ligament (ACL) of the knee, and the recruitment of patients lasted from March 2020 to November 2021.The clinical procedure used in this study is part of the standard health service provided to patients from admission to the hospital until discharge. Each patient was informed about the research’s purpose, methodology, examinations, and measurements. Criteria for inclusion in the study:Individuals of both genders aged 16 to 45 years.Diagnosed isolated anterior cruciate ligament knee rupture.Signed informed consent and agreement to participate in the research by the patient.Criteria for exclusion from the study:Patients undergoing a repeat anterior cruciate ligament surgery.Patients with additional injuries to the knee, including degenerative or rheumatoid processes, in addition to the anterior cruciate ligament rupture.Patients who developed severe general surgical complications during the study.Those who no longer wish to participate in the study without being obligated to explain their decision.The standard procedure for arthroscopic reconstruction of the ACL was performed in the operating room under spinal or general endotracheal anesthesia. The patient was placed in a supine position with the leg on an arthroscopic holder, and the operations were performed with the use of a tourniquet.The patellar tendon is accessed through a vertical skin incision from the middle of the patella to the lower part of the tibial tubercle, with the knee flexed. By separating the skin flaps, the paratenon is exposed and longitudinally incised to reveal the entire width of the patellar tendon. Using an oscillating saw, bone blocks are formed on the tibia and patella, measuring 25 mm in length and 10 mm in width. The middle third of the patellar ligament with the corresponding bone blocks is detached, and excess soft tissue is removed.To ensure a balanced and unbiased distribution of participants into the two groups, we employed a simple randomization technique. Before the surgery, sealed opaque envelopes containing allocation cards (either ‘Tubularized’ or ‘Standard’) were prepared by a research assistant not involved in the operative procedures or outcome assessment. As each patient was enrolled and met the inclusion criteria, an envelope was drawn randomly and opened by the operating surgeon, determining the graft preparation method for that particular patient. This approach ensured that each participant had an equal chance of being assigned to either of the groups, and the allocation sequence remained concealed until the point of intervention.Tubularization involved suturing the edges of the graft to form a tube shape from a flat ligament (All patients followed the same rehabilitation program [Data processing was performed using SPSS for Windows 20 program, which operates under the Microsoft Windows environment. The assumption of normal distribution of numerical feature results was examined using the Kolmogorov-Smirnov test. To compare the average postoperative scores (IKDC, Tegner, Lysholm, Lachman) between the two groups of patients (classical and tubularized ligament), the χ