A Study on Rosa Roxburghii for Knee Replacement Recovery

NCT07395856 | Not Yet Recruiting

• 1 other identifier: KYH20250018
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

Rosa roxburghii; Total Knee Arthroplasty; Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Oxidative Stress Markers

  Superoxide Dismutase (SOD): SOD activity will be measured in serum using a commercially available human-specific ELISA kit, following the manufacturer's instructions. Results are reported in U/L. Malondialdehyde (MDA): MDA concentration will be quantified in serum using a commercial ELISA kit based on the TBARS assay, following the manufacturer's protocol. Results are reported in nmol/mL or µmol/L.

  Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.

• Inflammatory Markers

  Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1 (IL-1), Interleukin-6 (IL-6): The concentrations of these pro-inflammatory cytokines will be measured in serum. Quantitative detection will be performed using specific, validated human ELISA kits. These cytokines are central mediators of the systemic inflammatory response; elevated levels post-surgery are associated with pain, tissue catabolism, and delayed recovery. The assay results will provide concentrations in picograms per milliliter (pg/mL).

  Preoperative 24 hours, postoperative 24 hours, and postoperative 72 hour.

• Visual Analogue Scale (VAS) Pain Score

  Assessment Method: Pain intensity will be subjectively assessed by the patient using a 100-mm horizontal line Visual Analogue Scale. The left endpoint (0 mm) is labeled "No pain," and the right endpoint (100 mm) is labeled "Worst imaginable pain." Patients will be instructed to mark a point on the line that best represents their pain intensity at that moment. Scoring: The distance from the "No pain" endpoint to the patient's mark is measured in millimeters, providing a score from 0 to 100. A higher score indicates greater pain intensity.

  Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks

• American Knee Society (AKS) Score

  Assessment Components: The AKS Score is a physician-administered assessment comprising two separate sub-scores: Knee Score (0-100 points): Evaluates the knee joint itself, focusing on pain (50 points), stability (25 points), and range of motion (25 points), while deducting points for flexion contracture, extension lag, and malalignment. Function Score (0-100 points): Evaluates the patient's functional ability, assessing walking distance (50 points) and stair climbing (50 points). The use of walking aids leads to point deductions. Criteria and Definition: A higher total score indicates better knee function and less impairment. The assessment will be performed by a trained orthopedic surgeon or research nurse through patient interview and physical examination. Specific criteria for pain levels, range of motion measurement using a goniometer, ligament stability tests, and observation of gait and stair navigation will be applied strictly according to the official AKS guidelines.

  Preoperative 24 hours, postoperative 24 hours, postoperative 72 hours, and postoperative 4 weeks.

Study Arms (2)

Rosa roxburghii

EXPERIMENTAL

Dietary Supplement: Rosa roxburghii

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Rosa roxburghii DIETARY_SUPPLEMENT

Enrolled patients will take 3g of Rosa roxburghii juice freeze-dried powder dissolved in 400-500ml of warm water with breakfast daily, starting from the day after surgery and continuing for 30 consecutive days.

Rosa roxburghii

Placebo OTHER

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.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shuguang Gao: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yumei Wu, BS

CONTACT

+86 15073738546; 2648565027@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 9, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL