Ethical approval
Ethical approval was obtained from the Ethics Committee of Baoding No.1 Central Hospital(2021-016).All study protocols were conformed to the principle of the Declaration of Helsinki.Written informed consents was obtained from each participant after study explanation.
Research object
Sixty-eight patients with knee osteoarthritis were conveniently recruited from a tertiary hospital in Baoding City between June 2021 and December 2021 and underwent knee replacement surgery. Inclusion criteria for this study include meeting the diagnostic criteria for knee osteoarthritis, undergoing primary unilateral knee replacement surgery, being between the ages of 50-80 years old, having no cognitive impairment, providing informed consent, and being able to cooperate with the investigation. Exclusion criteria involve suffering from serious heart, lung, kidney, or other important organ diseases, having diseases of the nervous system or musculoskeletal system that affect movement, or refusing to participate in the investigation.
Observed indicator
The questionnaire was developed by the research team based on a review of the literature and input from experts. It includes demographic and disease-related information such as gender, age, education level, marital status, main caregiver, chronic diseases, affected limbs, years of pain, pain score, preoperative knee flexion, body mass index (BMI), and duration operation time. The Tampa Scale for Kinesiophobia (TSK) consists of 17 items scored on a 4-point Likert scale ranging from 1 to 4. A score above 37 indicates kinesiophobia. The Numerical Rating Scale (NRS) for pain assesses pain levels on a scale of 0-10, with 0 indicating no pain, 1-3 mild pain, 4-6 moderate pain, and 7-10 severe pain.Active flexion of the knee joint involves the patient lying supine with the lower limbs extended as the starting point. The knee joint is then actively flexed to its maximum angle, and a long-arm protractor is used to measure the angle between the line connecting the greater trochanter of the femur to the lateral femoral condyle and the line connecting the lateral femoral condyle to the lateral malleolus. Record the time when the patient first gets out of bed, including the interval between returning to the ward after surgery and the first time they get out of bed, activity duration, activity distance, and pain level during the activity. On the day of discharge, perform the 2-Minute Walk Test (2-MWT) with a walking aid and record the distance traveled. Lastly, record the postoperative hospitalization time as the number of days from the second day after surgery to the patient's discharge date.
Research process
This study has been approved by the Ethics Committee of Baoding No.1 Central Hospital. Informed consent forms were signed by all participating patients. The patient's responsible nurse collected and filled out the general information questionnaire after the patient's admission to the hospital. Surgeries were conducted by a team of surgeons, with general anesthesia administered before the procedure. Adductor canal block was performed under ultrasound guidance. Prior to surgery, a pneumatic tourniquet was applied to the affected limb, with the pressure set between 40 kPa and 45 kPa. All surgeries utilized the medial approach to the patella, completed osteotomy, and employed Biomet Vaguard PS series prostheses.No drainage tube was left postoperatively. Following the operation, a rehabilitation exercise instruction manual will be provided to the patient by the nurse, while the attending doctor will guide them on the exercise techniques. The manual outlines daily postoperative rehabilitation exercises such as ankle pump exercises, quadriceps isometric exercises, passive and active knee flexion exercises, and specifies the frequency and duration of these exercises. The day after the patient regained consciousness and returned to the ward, the research team distributed the TSK rating scale to the patient, who completed it on site. In cases where the patient had difficulty understanding certain items, the research team members clarified them before the patient filled them out.The patient's pain level at rest was evaluated on multiple days postoperatively, including the first postoperative day (T1), second postoperative day (T2), third postoperative day (T3), fifth postoperative day (T4), and the day of discharge (T5). When the patient first got out of bed, they were accompanied by the responsible nurse, a research team member, and a family member. The research team recorded the time of activity initiation, duration, distance covered, and pain level during the activity.The patient's knee joint active flexion was measured by the attending physician on the first postoperative day (T1*), third postoperative day (T2*), fifth postoperative day (T3*), and the day of discharge (T4*) during ward rounds. Additionally, a 2-minute walk test was conducted on the morning of discharge under the supervision of the attending doctor, responsible nurse, a research team member, and a family member. The test was performed with the assistance of a walker, and the patient was instructed to complete it as quickly as tolerated. The postoperative hospitalization time was recorded by the research team members based on the patient's medical records.
Statistical analysis
SPSS 21.0 statistical software and GraphPad were utilized for data processing and statistical analysis. Group comparisons of count data were conducted using the chi-square or Fisher exact test and presented as numbers and percentages. For normally distributed measurement data, the mean ± standard deviation was reported, with group comparisons made using the independent sample t-test. The rank sum test was applied for data not adhering to normal distribution. Changes in postoperative pain level and active flexion of the knee joint were assessed using repeated measures analysis of variance. A p-value <0.05 was considered statistically significant.