Is Drainage Necessary After Total Hip Replacement?

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Device: Closed Suction Drainage System

• Registration Number: NCT02562586
• Lead Sponsor: University of Sao Paulo

Brief Summary

The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.

Detailed Description

After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Study First Submitted: 2015-08-17
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-28
• Last Update Submitted: 2015-09-28
• Study First Posted: 2015-09-29
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Primary Hip Arthroplasty
• Lateral Hardinge Approach
• Non-cemented Acetabular and Femoral Components
• Length of Skin Incision between 10 and 20 cm

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Exclusion Criteria

• Coagulative Disorders
• Previous Surgery in the same limb
• Age below 18 years old

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed Suction Drainage System	Closed Suction Drainage System	Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure

Primary Outcome Measures

Name	Time	Method
Change from baseline red blood cells (RBC)	Pre-operative and 24 Hours Postoperative	total RBC loss (mL) = \[Uncompensated RBC loss (mL)\] + \[Compensated RBC loss (mL)\] Uncompensated RBC loss (mL) = \[Initial RBC (mL)\] - \[Final RBC (mL)\] Compensated RBC loss (mL) = \[Sum of RBCs received from the various sources of transfusion\] Initial RBC (mL) = \[Estimated blood volume (mL)\] x \[Initial Hct level (%)\] at Day -1 Final RBC (mL) = \[Estimated blood volume (mL)\] x \[Final Hct level (%)\] at Day +3 Estimated blood volume (mL) = Women: \[Body surface area (m2)\] x 2430 Men: \[Body surface area (m2)\] x 2530 Body surface area (m2) = 0.0235 x \[Height (cm)\]0.42246 x \[Weight (kg)\]0.51456 Total blood loss at Hct level of 35% (mL) = \[Total blood loss (mL)\] / 0.35

Secondary Outcome Measures

Name	Time	Method
Erythrocyte sedimentation rate (ESR) (mm/h)	3,6 and 12 Weeks Postoperative
C-Reactive Protein (CRP) (mg/L)	3,6 and 12 Weeks Postoperative
Mid thigh circumference (cm)	Pre-operative and 24 Hours Postoperative to 3 Months Postoperative	Metric tape is placed midway between upper border of patella and superior anterior iliac spine
Complications	during 3 months follow-up

Trial Locations

Locations (1)

Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP; 🇧🇷 Sao Paulo, SP, Brazil