Clinical trial NCT06753448: Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Total Knee Arthroplasty
Official title: Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Primary Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Total Knee Arthroplasty
Venous Insufficiency of Leg
Keywords: Total knee arthroplasty
lower extremity swelling
inflammation
venous insufficiency
pain management
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included patients who underwent unilateral total knee arthroplasty.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lower extremity swelling
timeFrame: From enrollment to the end of the treatment at 2 weeks
Secondary outcomes:
measure: Pain
timeFrame: From enrollment to the end of the treatment at 2 weeks
measure: Range of motion
timeFrame: From enrollment to the end of the treatment at 2 weeks
measure: Blood C-reactive protein value as an inflammotory marker
timeFrame: From enrollment to the end of the treatment at 2 weeks
measure: Blood erythrocyte sedimentation rate as an inflammotory marker
timeFrame: From enrollment to the end of the treatment at 2 weeks
measure: Blood neutrophil/lymphocyte rate as an inflammatory marker
timeFrame: From enrollment to the end of the treatment at 2 weeks
measure: Panimmune value (neutrophil x platelet x monocyte / lymphocyte) as an inflammatory marker
timeFrame: From enrollment to the end of the treatment at 2 weeks
measure: The systemic immune-inflammation index (neutrophils × platelets/lymphocytes) as an inflammatory marker
timeFrame: From enrollment to the end of the treatment at 2 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.