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

NCT ID: NCT04508101

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2020-09-04

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.

Conditions

Blood Loss, Surgical

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

drainage group

Patients satisfying inclusion criteria who underwent either total as well as unicompartmental knee arthroplasty with suction drainage positioning

No interventions assigned to this group

non-drainage group

Patients satisfying inclusion criteria who underwent either total as well as unicompartmental knee arthroplasty without suction drainage positioning

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristiana Balbino, MD

Role: PRINCIPAL_INVESTIGATOR

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Central Contacts

PIERLUIGI PIRONTI, MD

Role: CONTACT

pierluigi.pironti@libero.it

+39 3385362097

References

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.

Reference Type: DERIVED

PMID: 34893042 (View on PubMed)

Other Identifiers

DRGIN1

Identifier Type: -

Identifier Source: org_study_id