Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty

Blood Loss, Surgical Clinical Trial

Official title:

The Role of Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty: a Comparative Retrospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04508101
• Other study ID #: DRGIN1
• Status: Not yet recruiting
• Start date: August 7, 2020
• Est. completion date: September 4, 2020

Study information

• Verified date: July 2020
• Source: Istituto Ortopedico Galeazzi
• Contact: PIERLUIGI PIRONTI, MD
• Phone: +39 3385362097
• Email: pierluigi.pironti[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although, suction drainage is routinely used in orthopedic clinical practice, there are still no precise guidelines on its use in total joint arthroplasty, particularly in total as well as unicompartmental knee arthroplasty. In fact, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Furthermore, the drain itself could interfere with knee mobilization, delaying its functional recovery. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of total as well as unicompartmental knee arthroplasty.

Description:

Knee arthroplasty is currently a widespread treatment either for osteoarthritis (OA) as well as other joint disorders. Specifically, total knee arthroplasty (TKA) is commonly considered one of the most effective orthopedic procedure in the treatment of end-stage knee OA as well as various rheumatic diseases such as rheumatoid arthritis, leading to a substantial pain relief and functional improvement. Besides, unicompartmental knee arthroplasty (UKA) represents a viable alternative in the treatment of unicompartmental knee OA showing a lower morbidity. Nevertheless, since knee arthroplasty involves soft tissue dissections and numerous bone cuts, several perioperative complications can be observed. Particularly, the subsequent local hemorrhage can lead to anemia, functional limitation, nerve palsy as well as increase in wound tension resulting in healing impairment. Moreover, the local hematoma could represent a growth environment for bacteria. Although TKA usually shows a higher hemorrhage rate, some patients undergoing UKA still show the aforementioned complications. Accordingly, intraarticular suction drainage placement can likely ease the hematoma drain, leading to swelling decrease, surgical wound healing improvement as well as reduction of postoperative infections. However, despite suction drainage is routinely used in TKA as well as UKA, there are still no precise guidelines and its effectiveness remains controversial. Indeed, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Moreover, the drainage conduit could obstruct physiotherapy leading to a delayed recovery. Therefore, since fast-track program has been increasingly applied in the management of TKA and UKA, an early drainage removal is recommended. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of TKA and UKA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 153
• Est. completion date: September 4, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• knee osteoarthritis diagnosis

• No contraindications to antithrombotic prophylaxis

• Availability of blood tests results before surgery as well as in the first three postoperative days.

• Detailed description of clinical records

Exclusion Criteria:

• contraindications to antithrombotic prophylaxis

• anti-platelet therapy

• knee arthroplasty revision indication

Related Conditions & MeSH terms

• Blood Loss, Surgical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin trend	Hemoglobin values comparison between the two groups	4 days
Secondary	Knee swelling	Evaluation of knee swelling during hospitalization (knee circumference variation > 2 cm)	5 days
Secondary	Wound bleeding	Evaluation of wound bleeding during hospitalization (number of dressing changed)	5 days
Secondary	Need for transfusion	Evaluation of transfusion rate during hospitalization (number of transfusions preformed)	5 days