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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

Tracking Information
First Submitted Date  ICMJE August 17, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date September 29, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • 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
  • C-Reactive Protein (CRP) (mg/L) [ Time Frame: 3,6 and 12 Weeks Postoperative ]
  • Erythrocyte sedimentation rate (ESR) (mm/h) [ Time Frame: 3,6 and 12 Weeks Postoperative ]
  • Complications [ Time Frame: during 3 months follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 28, 2015)
  • Visual Analogue Scale for Pain [ Time Frame: Pre-operative and 24 Hours Postoperative ]
    Scores range from 0 (no pain) to 10 (worst possible pain)
  • Harris Hip Score Questionnaire [ Time Frame: Pre-operative and 3 Months Postoperative ]
    <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Is Drainage Necessary After Total Hip Replacement?
Official Title  ICMJE Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Osteoarthritis, Hip
Intervention  ICMJE Device: Closed Suction Drainage System
patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure
Study Arms  ICMJE
  • 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
    Intervention: Device: Closed Suction Drainage System
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
92
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02562586
Other Study ID Numbers  ICMJE CEP 1055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose Ricardo Negreiros Vicente, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP