Knee OsteoarthritisNCT07342894
Effect of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate whether the timing of Hemovac drain removal affects early clinical outcomes after primary total knee arthroplasty (TKA). Hemovac drains are commonly used after TKA to reduce postoperative bleeding and swelling; however, the optimal timing for drain removal remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 10 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients diagnosed with knee osteoarthritis who underwent primary total knee arthroplasty at a single tertiary care center. All participants were treated according to standardized surgical and postoperative care protocols and were followed prospectively.
Who may be able to join
- Patients aged 18 years or older
- Diagnosis of knee osteoarthritis
- Undergoing primary total knee arthroplasty
- Provided written informed consent to participate in the study
Who cannot join
- Revision total knee arthroplasty
- History of inflammatory arthritis
- Known bleeding disorders or coagulopathy
- Active infection or periprosthetic joint infection
- Incomplete clinical data or loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Timing of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
This study aims to evaluate whether the timing of Hemovac drain removal affects early clinical outcomes after primary total knee arthroplasty (TKA). Hemovac drains are commonly used after TKA to reduce postoperative bleeding and swelling; however, the optimal timing for drain removal remains controversial.
In this prospective observational cohort study, patients undergoing primary TKA for knee osteoarthritis will be divided into two groups according to routine clinical practice: those whose drain is removed before the first postoperative rehabilitation session and those whose drain is removed after the first rehabilitation session.
The primary outcomes include the rate of postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain levels and functional outcomes. The results of this study may help optimize postoperative management strategies following total knee arthroplasty.
Read the detailed description
Total knee arthroplasty (TKA) is a widely performed surgical procedure for the treatment of advanced knee osteoarthritis. Postoperative management often includes the use of closed suction drains, such as Hemovac systems, to reduce hematoma formation and wound complications. However, the necessity and optimal timing of drain removal remain subjects of debate.
This prospective observational cohort study is designed to compare early clinical outcomes associated with two different timings of Hemovac drain removal following primary TKA. Patients who undergo primary TKA at a single tertiary care center will be enrolled prospectively. According to routine postoperative practice, patients will be allocated into two groups: drain removal before the first postoperative rehabilitation session or drain removal after completion of the first rehabilitation session.
All patients will receive standardized surgical techniques, anesthesia protocols, postoperative care, and rehabilitation programs. Data will be collected prospectively. Primary outcomes include postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain intensity and functional outcome measures.
This study aims to provide evidence to guide clinical decision-making regarding postoperative drain management in patients undergoing total knee arthroplasty.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Knee Osteoarthritis, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Drain Removal (Goup 1) | Patients whose Hemovac drain is removed before the first postoperative rehabilitation session as part of routine clinical practice. | |
| Late Drain Removal (Group 2) | Patients whose Hemovac drain is removed after completion of the first postoperative rehabilitation session as part of routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Drain Output
Total postoperative Hemovac drain output measured in milliliters following primary total knee arthroplasty.
Measured: Postoperative days 0-3
Secondary outcomes (4)
Length of Hospital Stay
Duration of postoperative hospital stay measured in days.
Measured: Postoperative days 0-discharge
Postoperative Hemoglobin Change
Change in hemoglobin level from preoperative baseline to postoperative measurement.
Measured: Postoperative first 24-48 hours
Knee Society Score (KSS)
Functional outcome assessed using the Knee Society Score.
Measured: Postoperative 1 month
Postoperative Pain Intensity
Pain intensity assessed using the Visual Analog Scale (VAS).
Measured: Postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 May 2025
- Primary completion30 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahan Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342894
- Sponsor's protocol ID
- TABED2-25-1015_TKA_DRAIN
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07342894
- Acronym / sponsor ID
- TABED2-25-1015_TKA_DRAIN
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Knee Osteoarthritis, Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 15 Jan 2026 (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.
This study aims to evaluate whether the timing of Hemovac drain removal affects early clinical outcomes after primary total knee arthroplasty (TKA). Hemovac drains are commonly used after TKA to reduce postoperative bleeding and swelling; however, the optimal timing for drain removal remains controversial.
In this prospective observational cohort study, patients undergoing primary TKA for knee osteoarthritis will be divided into two groups according to routine clinical practice: those whose drain is removed before the first postoperative rehabilitation session and those whose drain is removed after the first rehabilitation session.
The primary outcomes include the rate of postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain levels and functional outcomes. The results of this study may help optimize postoperative management strategies following total knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) is a widely performed surgical procedure for the treatment of advanced knee osteoarthritis. Postoperative management often includes the use of closed suction drains, such as Hemovac systems, to reduce hematoma formation and wound complications. However, the necessity and optimal timing of drain removal remain subjects of debate.
This prospective observational cohort study is designed to compare early clinical outcomes associated with two different timings of Hemovac drain removal following primary TKA. Patients who undergo primary TKA at a single tertiary care center will be enrolled prospectively. According to routine postoperative practice, patients will be allocated into two groups: drain removal before the first postoperative rehabilitation session or drain removal after completion of the first rehabilitation session.
All patients will receive standardized surgical techniques, anesthesia protocols, postoperative care, and rehabilitation programs. Data will be collected prospectively. Primary outcomes include postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain intensity and functional outcome measures.
This study aims to provide evidence to guide clinical decision-making regarding postoperative drain management in patients undergoing total knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Drain Removal (Goup 1) | – | –Patients whose Hemovac drain is removed before the first postoperative rehabilitation session as part of routine clinical practice. |
| Late Drain Removal (Group 2) | – | –Patients whose Hemovac drain is removed after completion of the first postoperative rehabilitation session as part of routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with knee osteoarthritis who underwent primary total knee arthroplasty at a single tertiary care center. All participants were treated according to standardized surgical and postoperative care protocols and were followed prospectively.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Diagnosis of knee osteoarthritis
- Undergoing primary total knee arthroplasty
- Provided written informed consent to participate in the study
Key exclusion criteria (5 listed)
- Revision total knee arthroplasty
- History of inflammatory arthritis
- Known bleeding disorders or coagulopathy
- Active infection or periprosthetic joint infection
- Incomplete clinical data or loss to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Drain Output
Time frame: Postoperative days 0-3
Total postoperative Hemovac drain output measured in milliliters following primary total knee arthroplasty.
4 secondary outcomes
Length of Hospital Stay
Time frame: Postoperative days 0-discharge
Postoperative Hemoglobin Change
Time frame: Postoperative first 24-48 hours
Knee Society Score (KSS)
Time frame: Postoperative 1 month
Postoperative Pain Intensity
Time frame: Postoperative 1 month
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 Jan 2026.
- Individual participant dataSharing planned: No
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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 Knee Osteoarthritis and Total Knee Arthroplasty, run by Ankara City Hospital Bilkent 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 4 inclusion and 5 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 Jan 2026. 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?
Postoperative Drain Output (time frame: Postoperative days 0-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.