Total Knee ArthroplastyNCT06753448
Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty and Venous Insufficiency of Leg, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Venous Insufficiency of Leg
- What is being tested?
- Diosmin and Hesperidin Combination
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2024to 10 Jun 2025
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included patients who underwent unilateral total knee arthroplasty.
Who may be able to join
- Patients who underwent unilateral primary total knee replacement surgery
- Patients who are functionally ASA 1, ASA 2 or ASA 3.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06070
About this study
Official title: Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Primary Total Knee Arthroplasty
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.
- Being tested
- Diosmin and Hesperidin Combination
- Keywords
- Total knee arthroplasty, lower extremity swelling, inflammation, venous insufficiency, pain management
- Medical subject headings
- Inflammation, Venous Insufficiency, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diosmin and Hesperidin CombinationDrug
Participants will take diosmin and hesperidin combination for 14 days after total knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Participants will take diosmin and hesperidin combination in addition to standard therapy for 14 days after total knee replacement surgery. Receives: Drug: Diosmin and Hesperidin Combination | |
| Control group | Participants will only take standard therapy for 14 days after total knee replacement surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the treatment at 2 weeks
Secondary outcomes (7)
Pain
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.
Measured: From enrollment to the end of the treatment at 2 weeks
Range of motion
Knee range of motion is measured with goniometer.
Measured: From enrollment to the end of the treatment at 2 weeks
Blood C-reactive protein value as an inflammotory marker
Measured: From enrollment to the end of the treatment at 2 weeks
Blood erythrocyte sedimentation rate as an inflammotory marker
Measured: From enrollment to the end of the treatment at 2 weeks
Blood neutrophil/lymphocyte rate as an inflammatory marker
Measured: From enrollment to the end of the treatment at 2 weeks
Panimmune value (neutrophil x platelet x monocyte / lymphocyte) as an inflammatory marker
Measured: From enrollment to the end of the treatment at 2 weeks
The systemic immune-inflammation index (neutrophils × platelets/lymphocytes) as an inflammatory marker
Measured: From enrollment to the end of the treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start8 Oct 2024
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Berkay Girgin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753448
- Sponsor's protocol ID
- 2024-1008
- Status last verified
- Jul 2025
- First submitted
- 18 Dec 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38109425Fotiadis 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.
PubMed 21274547Nicolaides 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.
PubMed 31970659
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06753448
- Acronym / sponsor ID
- 2024-1008
- Keywords
- Total knee arthroplasty, lower extremity swelling, inflammation, venous insufficiency, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Diosmin and Hesperidin CombinationParticipants will take diosmin and hesperidin combination in addition to standard therapy for 14 days after total knee replacement surgery. |
| Control group | – | –Participants will only take standard therapy for 14 days after total knee replacement surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients who underwent unilateral total knee arthroplasty.
Key inclusion criteria (2 listed)
- Patients who underwent unilateral primary total knee replacement surgery
- Patients who are functionally ASA 1, ASA 2 or ASA 3.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diosmin and Hesperidin CombinationParticipants will take diosmin and hesperidin combination for 14 days after total knee replacement surgery. | Drug | Study group |
Primary outcome
Lower extremity swelling
Time frame: 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.
7 secondary outcomes
Pain
Time frame: From enrollment to the end of the treatment at 2 weeks
Range of motion
Time frame: From enrollment to the end of the treatment at 2 weeks
Blood C-reactive protein value as an inflammotory marker
Time frame: From enrollment to the end of the treatment at 2 weeks
Blood erythrocyte sedimentation rate as an inflammotory marker
Time frame: From enrollment to the end of the treatment at 2 weeks
Blood neutrophil/lymphocyte rate as an inflammatory marker
Time frame: From enrollment to the end of the treatment at 2 weeks
Panimmune value (neutrophil x platelet x monocyte / lymphocyte) as an inflammatory marker
Time frame: From enrollment to the end of the treatment at 2 weeks
The systemic immune-inflammation index (neutrophils × platelets/lymphocytes) as an inflammatory marker
Time frame: From enrollment to the end of the treatment at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Results publication: PubMed 38109425Wang 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.
- Results publication: PubMed 21274547Fotiadis 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.
- Results publication: PubMed 31970659Nicolaides 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Venous Insufficiency of Leg, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity swelling (time frame: From enrollment to the end of the treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06753448, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.