Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:26 AM
Study NCT ID:
NCT07342894
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
Effect of Timing of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: