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

NCT06753448 | Completed

• 1 other identifier: 2024-1008
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Venous Insufficiency of Leg

Keywords

Total knee arthroplasty; lower extremity swelling; inflammation; venous insufficiency; pain management

Outcome Measures

Primary Outcomes (1)

• Lower extremity swelling

  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.

  From enrollment to the end of the treatment at 2 weeks

Secondary Outcomes (7)

• Pain

  From enrollment to the end of the treatment at 2 weeks

• Range of motion

  From enrollment to the end of the treatment at 2 weeks

• 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

Study Arms (2)

Study group

Participants will take diosmin and hesperidin combination in addition to standard therapy for 14 days after total knee replacement surgery.

Drug: Diosmin and Hesperidin Combination

Control group

Participants will only take standard therapy for 14 days after total knee replacement surgery.

Interventions

Diosmin and Hesperidin Combination DRUG

Participants will take diosmin and hesperidin combination for 14 days after total knee replacement surgery.

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study included patients who underwent unilateral total knee arthroplasty.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06070, Turkey (Türkiye)

Location

Related Publications (3)

• Wang Q, Jin Q, Cai L, Zhao C, Feng P, Jia J, Xu W, Qian Q, Ding Z, Xu J, Gu C, Zhang S, Shi H, Ma H, Deng Y, Zhang T, Song Y, Wang Q, Zhang Y, Zhou X, Pei L, Yang Y, Liang J, Jiang T, Li H, Liu H, Wu L, Kang P. Efficacy of Diosmin in Reducing Lower-Extremity Swelling and Pain After Total Knee Arthroplasty: A Randomized, Controlled Multicenter Trial. J Bone Joint Surg Am. 2024 Mar 20;106(6):492-500. doi: 10.2106/JBJS.23.00854. Epub 2023 Dec 18.

  PMID: 38109425 BACKGROUND

• Fotiadis E, Kenanidis E, Samoladas E, Chytas A, Lyrtzis C, Koimtzis M, Chalidis B. Are venotonic drugs effective for decreasing acute posttraumatic oedema following ankle sprain? A prospective randomized clinical trial. Arch Orthop Trauma Surg. 2011 Mar;131(3):389-92. doi: 10.1007/s00402-011-1266-9. Epub 2011 Jan 28.

  PMID: 21274547 BACKGROUND

• Nicolaides AN. The Benefits of Micronized Purified Flavonoid Fraction (MPFF) Throughout the Progression of Chronic Venous Disease. Adv Ther. 2020 Feb;37(Suppl 1):1-5. doi: 10.1007/s12325-019-01218-8. Epub 2020 Jan 22.

  PMID: 31970659 BACKGROUND

MeSH Terms

Conditions

Inflammation; Venous Insufficiency; Agnosia

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: October 8, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

TU (1)