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Is Drainage Necessary After Total Hip Replacement?

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ClinicalTrials.gov Identifier: NCT02562586
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jose Ricardo Negreiros Vicente, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: Closed Suction Drainage System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562586


Locations
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Brazil
Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
Sao Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
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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:
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Responsible Party: Jose Ricardo Negreiros Vicente, Head of Hip Surgery Group, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02562586     History of Changes
Other Study ID Numbers: CEP 1055
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Jose Ricardo Negreiros Vicente, University of Sao Paulo:
Suction
Arthroplasty
Replacement
Hip

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases