Clinical trial NCT04508101: Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty
Official title: The Role of Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty: a Comparative Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Loss, Surgical
Keywords: suction drainage
total knee arthtoplasty
unicompartmental knee arthroplasty
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected from knee osteoarthritis with total as well as unicompartmental knee arthroplasty indication.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin trend
timeFrame: 4 days
Secondary outcomes:
measure: Knee swelling
timeFrame: 5 days
measure: Wound bleeding
timeFrame: 5 days
measure: Need for transfusion
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
name: Cristiana Balbino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manta N, Mangiavini L, Balbino C, Colombo A, Pandini EG, Pironti P, Vigano M, D'Anchise R. The role of suction drainage in the management of peri-operative bleeding in Total and Unicomcompartmental knee arthroplasty: a retrospective comparative study. BMC Musculoskelet Disord. 2021 Dec 10;22(1):1031. doi: 10.1186/s12891-021-04868-4.