Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Total Knee Arthroplasty

• Conditions: Total Knee Arthroplasty; Venous Insufficiency of Leg
• Interventions: Drug: Diosmin and Hesperidin Combination

• Registration Number: NCT06753448
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

The goal of this clinical trial is to find out the efficacy of diosmin and hesperidin on postoperative early rehabilitation after primary total knee arthroplasty. The main questions it aims to answer are:

Does diosmin and hesperidin combined drug decreases the lower extremity swelling, pain and increases the range of motion after primary total knee arthroplasty surgery compared to standard therapy group? Does diosmin and hesperidin combined drug decreases inflammation after total knee arthroplasty surgery.

Participants will take diosmin and hesperidin in addition to standard therapy for 14 days after total knee arthroplasty surgery. Lower extremity swelling, pain and range of motion of the patients will be recorded in every visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-08
• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who underwent unilateral primary total knee replacement surgery
• Patients who are functionally ASA 1, ASA 2 or ASA 3.

Exclusion Criteria

• Patients >80 years or <18 years of age
• Patients with liver insufficiency
• Patients with allergy to diosmin or hesperidin
• Patients which are not capable to communicate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Diosmin and Hesperidin Combination	Participants will take diosmin and hesperidin combination in addition to standard therapy for 14 days after total knee replacement surgery.

Primary Outcome Measures

Name	Time	Method
Lower extremity swelling	From enrollment to the end of the treatment at 2 weeks	Lower extremity swelling is measured by measuring extremity diameters from 3 points (below patella, patella and above patella) and noted. Then percentage of increment or decrement of diameters is measured.

Secondary Outcome Measures

Name	Time	Method
Pain	From enrollment to the end of the treatment at 2 weeks	The Visual Analog Scale is used to describe patients' pain. It is a scale that describes pain by giving numbers from 0 to 10. 0 means no pain and 10 means extreme pain.
Range of motion	From enrollment to the end of the treatment at 2 weeks	Knee range of motion is measured with goniometer.
Blood C-reactive protein value as an inflammotory marker	From enrollment to the end of the treatment at 2 weeks
Blood erythrocyte sedimentation rate as an inflammotory marker	From enrollment to the end of the treatment at 2 weeks
Blood neutrophil/lymphocyte rate as an inflammatory marker	From enrollment to the end of the treatment at 2 weeks
Panimmune value (neutrophil x platelet x monocyte / lymphocyte) as an inflammatory marker	From enrollment to the end of the treatment at 2 weeks
The systemic immune-inflammation index (neutrophils × platelets/lymphocytes) as an inflammatory marker	From enrollment to the end of the treatment at 2 weeks

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey