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Comparison of two types of procedures used to prevent venous thrombosis after total knee prosthesis surgery: with medication or mechanical device

Comparison of the effect of the type of Thromboprophylaxis (Mechanical or Pharmacological) on blood loss and postoperative edema in total knee arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8k2vpx
Enrollment
Unknown
Registered
2019-06-04
Start date
2019-06-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee

Interventions

Each group will have 75 patients (150 in total). Patients undergoing total knee arthroplasty will be included and randomly assigned to two groups. The study group will receive a mechanical interventio
D09.698.373.400.300.200

Sponsors

Hospital Maradei
Lead Sponsor
Faculdade de Medicina da Universidade de São Paulo (FMUSP)
Collaborator
Universidade Federal do Pará
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adult patients submitted to total knee arthroplasty

Exclusion criteria

Exclusion criteria: Personal history of venous thromboembolism (deep vein thrombosis or pulmonary embolism); coagulation disorders; peptic ulcer disease; liver disease; enoxaparin allergy; malignant tumors; patients undergoing any surgery in the last three months.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Evaluate the edema, measured in centimeters, by the circumference of the thigh, leg and ankle, 3 days after surgery. We expect the edema (thigh, leg and ankle) is greater with pharmacological thromboprophylaxis than with the mechanical method;Found outcome 1: Edema was greater in patients with pharmacological prophylaxis than with mechanical, at the three measured sites: thigh, leg and ankle, but this variation was statistically significant only in the leg (p equal to 0.002) and ankle (p lower than 0.001)

Secondary

MeasureTime frame
Expected outcome 2: Evaluate blood loss verified by the drain volume (ml) and the drop of hemoglobin (g/dl) and hematocrit rate(%), measured preoperatively and 48 h after surgery. We expect that blood loss is greater with pharmacological thromboprophylaxis than with the mechanical method. ;Found Outcome 2: the blood loss was greater in the pharmacological group, as seen by the drain volume (p lower than 0.001), as well as the drop in hemoglobin (p equal to 0.001) and hematocrit (p equal to 0.001).

Countries

Brazil

Contacts

Public ContactJoão Alberto Maradei Pereira

Universidade Federal do Pará

jamaradei@me.com+55(91) 98889 0712

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 11, 2026