NCT07342894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

December 22, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

Knee OsteoarthritisTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Postoperative Drain Output

    Total postoperative Hemovac drain output measured in milliliters following primary total knee arthroplasty.

    Postoperative days 0-3

Secondary Outcomes (4)

  • Length of Hospital Stay

    Postoperative days 0-discharge

  • Postoperative Hemoglobin Change

    Postoperative first 24-48 hours

  • Knee Society Score (KSS)

    Postoperative 1 month

  • Postoperative Pain Intensity

    Postoperative 1 month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients aged 18 years or older
  • Diagnosis of knee osteoarthritis
  • Undergoing primary total knee arthroplasty
  • Provided written informed consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, specialist

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 15, 2026

Study Start

May 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 10, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations