Evaluation of Blood Loss During Knee Arthroplasty

NCT06052982 | Completed

• 1 other identifier: ID RCB : 2019-A01710-57
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blood; Loss; Drainage; Without drainage

Outcome Measures

Primary Outcomes (1)

• Hemoglobin dosage and bleeding quantification in both groups

  Estimation of blood loss with Mercuriali Formula. This formula requires the patient's blood volume and requires the volume of red blood cells transfused as well.

  from the day before surgery until the 5th postoperative day

Secondary Outcomes (2)

• Assessment of blood transfusion during primary knee arthroplasty

  from surgery until the 5th postoperative day

• Number of patients with complications after knee arthroplasty in the two groups

  From surgery up to the third month

Study Arms (2)

Drain

OTHER

At the end of the knee arthroplasty, a drain is placed at the surgical site

Procedure: Drainage

Without drain

OTHER

At the end of the knee arthroplasty, a drain is not placed at the surgical site

Procedure: Drainage

Interventions

Drainage PROCEDURE

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

Drain; Without drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consent
• Patient aged over 18 years
• Patient scheduled for primary knee arthroplasty

You may not qualify if:

• Patient expresses his/her opposition to participating in the study
• Patient scheduled for revision, revision or totalization arthroplasty
• Primary arthroplasty after septic arthritis
• Patient requiring an additional planned or unplanned surgical procedure such as TTTA, osteosynthesis for an intraoperative fracture and/or removal of material

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Luc LHOTELLIER, MD

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: September 25, 2023
• Study Start: April 10, 2022
• Primary Completion: April 10, 2023
• Study Completion: July 10, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)