- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342894
Effect of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years or older
- Diagnosis of knee osteoarthritis
- Undergoing primary total knee arthroplasty
- Provided written informed consent to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Early Drain Removal (Goup 1)
Patients whose Hemovac drain is removed before the first postoperative rehabilitation session as part of routine clinical practice.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Drain Output
Time Frame: Postoperative days 0-3
|
Total postoperative Hemovac drain output measured in milliliters following primary total knee arthroplasty.
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Postoperative days 0-3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay
Time Frame: Postoperative days 0-discharge
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Duration of postoperative hospital stay measured in days.
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Postoperative days 0-discharge
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Postoperative Hemoglobin Change
Time Frame: Postoperative first 24-48 hours
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Change in hemoglobin level from preoperative baseline to postoperative measurement.
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Postoperative first 24-48 hours
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Knee Society Score (KSS)
Time Frame: Postoperative 1 month
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Functional outcome assessed using the Knee Society Score.
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Postoperative 1 month
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Postoperative Pain Intensity
Time Frame: Postoperative 1 month
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Pain intensity assessed using the Visual Analog Scale (VAS).
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Postoperative 1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABED2-25-1015_TKA_DRAIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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