Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:08 PM
Study NCT ID:
NCT07395856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Rosa Roxburghii for Knee Replacement Recovery
Sponsor:
Shuguang Gao
Organization:
Study Overview
Official Title:
A Study on the Involvement of Rosa Roxburghii in Oxidative Stress in Knee Osteoarthritis and Its Impact on Rehabilitation of Patients After Total Knee Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trail is to investigates the effect of Rosa roxburghii juice freeze-dried powder on the recovery of patients undergoing total knee arthroplasty due to knee osteoarthritis. The participants are divided into an experimental group and a placebo group. Enrolled patients will take 3g of Rosa roxburghii juice freeze-dried powder or a placebo dissolved in 400-500ml of warm water with breakfast daily, starting from the day after surgery and continuing for 30 consecutive days. Data on inflammatory markers, oxidative stress indicators, and knee function scores will be collected from the participants one day before surgery, as well as on the first, third, and thirtieth days after surgery.
Detailed Description:
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:
1. 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.
2. 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:
3. 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.
4. 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:
1. Baseline Data: Gender, age, BMI, ethnicity, occupation, education level, living and residential situation, medical history, etc.
2. Intraoperative Parameters: Operation duration, anesthesia duration, intraoperative blood loss, intraoperative average heart rate and blood pressure, etc.
3. Record adverse reactions such as wound bleeding, infection, etc.
4. Oxidative Stress Markers: Superoxide dismutase (SOD) and malondialdehyde (MDA) content measured by ELISA at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
5. Inflammatory Markers (4ml blood per draw): TNF-α, IL-1, IL-6 levels measured by ELISA at preoperative 24h, postoperative 24h, and 72h.
6. 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.
7. American Knee Society (AKS) Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
Perioperative Management:
1. 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.
2. 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:
3. 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.
4. 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:
1. Baseline Data: Gender, age, BMI, ethnicity, occupation, education level, living and residential situation, medical history, etc.
2. Intraoperative Parameters: Operation duration, anesthesia duration, intraoperative blood loss, intraoperative average heart rate and blood pressure, etc.
3. Record adverse reactions such as wound bleeding, infection, etc.
4. Oxidative Stress Markers: Superoxide dismutase (SOD) and malondialdehyde (MDA) content measured by ELISA at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
5. Inflammatory Markers (4ml blood per draw): TNF-α, IL-1, IL-6 levels measured by ELISA at preoperative 24h, postoperative 24h, and 72h.
6. 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.
7. American Knee Society (AKS) Score: Recorded at preoperative 24h, postoperative 24h, 72h, and 4 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: