Is Drainage Necessary After Total Hip Replacement?

September 28, 2015 updated by: Jose Ricardo Negreiros Vicente, University of Sao Paulo

Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-010
        • Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Closed Suction Drainage System
Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure
Device: Closed Suction Drainage System
patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure
No Intervention: No Closed Suction Drainage System
Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline red blood cells (RBC)
Time Frame: 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
Pre-operative and 24 Hours Postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid thigh circumference (cm)
Time Frame: 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
Pre-operative and 24 Hours Postoperative to 3 Months Postoperative
C-Reactive Protein (CRP) (mg/L)
Time Frame: 3,6 and 12 Weeks Postoperative
3,6 and 12 Weeks Postoperative
Erythrocyte sedimentation rate (ESR) (mm/h)
Time Frame: 3,6 and 12 Weeks Postoperative
3,6 and 12 Weeks Postoperative
Complications
Time Frame: during 3 months follow-up
during 3 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for Pain
Time Frame: Pre-operative and 24 Hours Postoperative
Scores range from 0 (no pain) to 10 (worst possible pain)
Pre-operative and 24 Hours Postoperative
Harris Hip Score Questionnaire
Time Frame: Pre-operative and 3 Months Postoperative
<70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
Pre-operative and 3 Months Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Jose Ricardo Negreiros Vicente, MD PhD, Hip Surgery Group Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 1055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Hip

Clinical Trials on Closed Suction Drainage System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe