Effect of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty

NCT ID: NCT07342894

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-10

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Drain Removal (Goup 1)

Patients whose Hemovac drain is removed before the first postoperative rehabilitation session as part of routine clinical practice.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Şahan Güven

Medical Doctor, specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TABED2-25-1015_TKA_DRAIN

Identifier Type: -

Identifier Source: org_study_id