An interventional study of Drainage in Primary Knee Arthroplasty, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon · Not applicable, Interventional, and Other
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.
After obtaining the patient's consent and randomisation, the operating surgeon will have the information of placing or not a drain, lately at the end of the intervention so that the course of the intervention is not influenced by the prior knowledge of the patient randomization arm.
Investigators will carry out especially within the framework of this research 3 samples of a total of 10.7 ml of whole blood (appendix. 12.5) distributed as follows:
Sample no. 1 : 2.7 ml of blood in a hemostasis tube (sodium citrate tube) one day before the procedure (D-1) for the determination of the prothrombin level (PT), activated partial thromboplastin time ( TCA) and the INR or International Normalized Ratio.
Sample no. 2 : 4 ml of blood in a purple EDTA tube for NFS, one day before the operation (D-1) for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) Sample no. 3 : 4 ml of blood in a violet EDTA tube for NFS for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) on the fifth postoperative day (D5). This last assessment will be prescribed to the patient to be carried out in the rehabilitation center..
The knee prosthesis implantation surgical technique is performed according to the standard operating procedure of the orthopedic surgery team.
According to the operating standard procedure of our orthopedic department, the drain is non-aspirated for 6 hours and then put back under vacuum until the morning after the knee prosthesis operation.
Three months after the intervention the patient will be seen again in consultation and examined.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 510 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Groupe Hospitalier Diaconesses Croix Saint-Simon is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At the end of the knee arthroplasty, a drain is placed at the surgical site
Procedure: Drainage
At the end of the knee arthroplasty, a drain is not placed at the surgical site
Procedure: Drainage
At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result
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.
Time frame: from the day before surgery until the 5th postoperative day
Assessment of blood transfusion during primary knee arthroplasty
Measurement of total blood transfused between surgery and the fifth day after surgery
Time frame: from surgery until the 5th postoperative day
Number of patients with complications after knee arthroplasty in the two groups
Monitoring for complications from surgery up to 3 months
Time frame: From surgery up to the third month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Diaconesses Croix Saint-Simon