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

NCT04508101 | Unknown DMC

• 1 other identifier: DRGIN1
• Study Type: observational
• Target: 153
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Loss, Surgical

Keywords

suction drainage; total knee arthtoplasty; unicompartmental knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Hemoglobin trend

  Hemoglobin values comparison between the two groups

  4 days

Secondary Outcomes (3)

• Knee swelling

  5 days

• Wound bleeding

  5 days

• Need for transfusion

  5 days

Study Arms (2)

drainage group

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

non-drainage group

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected from knee osteoarthritis with total as well as unicompartmental knee arthroplasty indication.

You may qualify if:

• 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

You may not qualify if:

• contraindications to antithrombotic prophylaxis
• anti-platelet therapy
• knee arthroplasty revision indication

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Related Publications (1)

• 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.

  PMID: 34893042 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Cristiana Balbino, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PIERLUIGI PIRONTI, MD

CONTACT

+39 3385362097; pierluigi.pironti@libero.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: August 7, 2020
• Primary Completion: August 24, 2020
• Study Completion: September 4, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-07