A Study on Rosa Roxburghii for Knee Replacement Recovery

Cohort Setting: Two cohorts: Intervention group (TTRJ group) receiving standard postoperative rehabilitation plus freeze-dried RRTJ juice powder; Control group receiving standard postoperative rehabilitation plus an equal dose of placebo.

Perioperative Management:

• Anesthesia: All patients receive postoperative analgesia education and VAS scale training one day preoperatively and sign informed consent. Routine fasting for 12 hours preoperatively. Upon entering the operating room, venous access is established, and ECG, non-invasive blood pressure, and pulse oximetry are monitored. General anesthesia is used.
• Surgical Procedure: TKA via anterior midline approach. After incising the deep fascia, the patella is everted to expose the joint surfaces. Hyperplastic synovium within the joint cavity is excised, preserving the infrapatellar fat pad. Distal femur, tibial plateau, anterior/posterior femoral condyles, chamfer, and intercondylar notch cuts are performed. Trial components are placed, and alignment is checked. Synovectomy around the patellar margin is performed, with patellofemoral joint shaping and denervation. The surgical field is thoroughly irrigated. Bone cement is mixed, prostheses are implanted, and the wound is closed in layers and dressed.

Treatment Methods:

• Control Group: Within 24h postoperatively, anteroposterior and lateral knee X-rays are taken to confirm proper prosthesis placement. Patients are instructed to perform knee function rehabilitation exercises according to the plan. Starting from the first postoperative day, patients take placebo 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks.
• TTRJ Group: Within 24h postoperatively, anteroposterior and lateral knee X-rays are taken to confirm proper prosthesis placement. Patients are instructed to perform knee function rehabilitation exercises according to the plan. Starting from the first postoperative day, patients take freeze-dried RRTJ powder 3g/day after breakfast, dissolved in 200ml of warm water (40-50°C), for 4 consecutive weeks. The freeze-dried RRTJ juice powder used is the "Jin Ci Li" brand produced by China National Pharmaceutical Group Guizhou Great Health Industry Development Co., Ltd.

Measurement Parameters:

• Baseline Data: Gender, age, BMI, ethnicity, occupation, education level, living and residential situation, medical history, etc.
• Intraoperative Parameters: Operation duration, anesthesia duration, intraoperative blood loss, intraoperative average heart rate and blood pressure, etc.
• Record adverse reactions such as wound bleeding, infection, etc.
• Oxidative Stress Markers: Superoxide dismutase (SOD) and malondialdehyde (MDA) content measured by ELISA at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
• Inflammatory Markers (4ml blood per draw): TNF-α, IL-1, IL-6 levels measured by ELISA at preoperative 24h, postoperative 24h, and 72h.
• Visual Analogue Scale (VAS) Pain Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks during rest and activity (walking or maximum knee flexion). Patients are explained the VAS before assessment.
• American Knee Society (AKS) Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks.

Inclusion criteria

• diagnostic criteria for primary knee osteoarthritis (KOA) as defined by the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2019 Edition)."
• Aged between 18 and 75 years.
• No history of trauma or surgery involving the lower limbs. Scheduled to undergo total knee arthroplasty (TKA) performed by the same surgical team at the participating hospital.
• Willing to refrain from participating in any other clinical research studies for the duration of this trial.
• Agrees to adhere to the complete study treatment regimen.
• Able and willing to provide written informed consent.

Exclusion criteria

• Has a preoperative knee joint infection, rheumatoid arthritis, or other concurrent inflammatory or non-inflammatory joint disease.
• Has a history of any prior knee surgery (including revision procedures).
• Has diabetes mellitus with poorly controlled glucose levels (fasting blood glucose >7.2 mmol/L or 2-hour postprandial blood glucose >11.1 mmol/L).

Has severe, unstable, or uncontrolled disease of the circulatory, respiratory, or hematopoietic systems.

• Has obesity defined as a body mass index (BMI) ≥30 kg/m².
• Has a diagnosis of severe osteoporosis.
• Is pregnant or currently breastfeeding.
• Has an active psychiatric disorder or any other condition that, in the investigator's judgment, would impair the ability to provide informed consent or comply with study procedures.