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Evaluation of Blood Loss During Knee Arthroplasty

NCT06052982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2023-09-25

No results posted yet for this study

Summary

Primary arthroplasties are frequent interventions that can present hemorrhagic complications: postoperative hematoma, deglobulization justifying monitoring blood tests and blood transfusion if necessary.

The attitude regarding the drainage of the surgical site supposed to limit these events differs from one surgeon to another, even in the same team. Its use is common practice; for some, systematic. For others, depending on intraoperative findings or the patient's condition. For others, the drain is never laid.

Faced with the divergence of data from the literature on the benefit of the placement of a drain for intra and postoperative bleeding in knee arthroplasty, the lack of randomized prospective studies on large series of patients, and in a desire to homogenization and standardization of the operating procedure of our surgeons, investigators decided to conduct this prospective interventional, comparative and randomized study.

Conditions

  • Primary Knee Arthroplasty

Interventions

PROCEDURE

Drainage

At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Principal Investigators

  • Luc LHOTELLIER, MD · Groupe Hospitalier Diaconesses Croix Saint-Simon

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-10
Primary Completion
2023-04-10
Completion
2023-07-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052982 on ClinicalTrials.gov