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Completed

NCT Number: NCT02562586

Is Drainage Necessary After Total Hip Replacement?

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed Suction Drainage System

Device

patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. C-Reactive Protein (CRP) (mg/L)

    Time frame: 3,6 and 12 Weeks Postoperative

  3. Erythrocyte sedimentation rate (ESR) (mm/h)

    Time frame: 3,6 and 12 Weeks Postoperative

  4. Complications

    Time frame: during 3 months follow-up

Other outcomes

  1. Visual Analogue Scale for Pain

    Time frame: Pre-operative and 24 Hours Postoperative

    Scores range from 0 (no pain) to 10 (worst possible pain)

  2. Harris Hip Score Questionnaire

    Time frame: Pre-operative and 3 Months Postoperative

    <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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