Is Drainage Necessary After Total Hip Replacement?
Primary Purpose
Osteoarthritis, Hip
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Closed Suction Drainage System
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis, Hip focused on measuring Suction, Arthroplasty, Replacement, Hip
Eligibility 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
Sites / Locations
- Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Closed Suction Drainage System
No Closed Suction Drainage System
Arm Description
Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure
Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure
Outcomes
Primary Outcome Measures
Change from baseline red blood cells (RBC)
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
Mid thigh circumference (cm)
Metric tape is placed midway between upper border of patella and superior anterior iliac spine
C-Reactive Protein (CRP) (mg/L)
Erythrocyte sedimentation rate (ESR) (mm/h)
Complications
Full Information
NCT ID
NCT02562586
First Posted
August 17, 2015
Last Updated
September 28, 2015
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02562586
Brief Title
Is Drainage Necessary After Total Hip Replacement?
Official Title
Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Suction, Arthroplasty, Replacement, Hip
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Closed Suction Drainage System
Arm Type
Active Comparator
Arm Description
Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure
Arm Title
No Closed Suction Drainage System
Arm Type
No Intervention
Arm Description
Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure
Intervention Type
Device
Intervention Name(s)
Closed Suction Drainage System
Intervention Description
patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure
Primary Outcome Measure Information:
Title
Change from baseline red blood cells (RBC)
Description
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
Time Frame
Pre-operative and 24 Hours Postoperative
Secondary Outcome Measure Information:
Title
Mid thigh circumference (cm)
Description
Metric tape is placed midway between upper border of patella and superior anterior iliac spine
Time Frame
Pre-operative and 24 Hours Postoperative to 3 Months Postoperative
Title
C-Reactive Protein (CRP) (mg/L)
Time Frame
3,6 and 12 Weeks Postoperative
Title
Erythrocyte sedimentation rate (ESR) (mm/h)
Time Frame
3,6 and 12 Weeks Postoperative
Title
Complications
Time Frame
during 3 months follow-up
Other Pre-specified Outcome Measures:
Title
Visual Analogue Scale for Pain
Description
Scores range from 0 (no pain) to 10 (worst possible pain)
Time Frame
Pre-operative and 24 Hours Postoperative
Title
Harris Hip Score Questionnaire
Description
<70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
Time Frame
Pre-operative and 3 Months Postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Ricardo Negreiros Vicente, MD PhD
Organizational Affiliation
Hip Surgery Group Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23982636
Citation
Zhou XD, Li J, Xiong Y, Jiang LF, Li WJ, Wu LD. Do we really need closed-suction drainage in total hip arthroplasty? A meta-analysis. Int Orthop. 2013 Nov;37(11):2109-18. doi: 10.1007/s00264-013-2053-8. Epub 2013 Aug 28.
Results Reference
background
PubMed Identifier
15022802
Citation
Gonzalez Della Valle A, Slullitel G, Vestri R, Comba F, Buttaro M, Piccaluga F. No need for routine closed suction drainage in elective arthroplasty of the hip: a prospective randomized trial in 104 operations. Acta Orthop Scand. 2004 Feb;75(1):30-3. doi: 10.1080/00016470410001708050.
Results Reference
background
PubMed Identifier
23917702
Citation
Chen ZY, Gao Y, Chen W, Li X, Zhang YZ. Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2014 Aug;24(6):939-46. doi: 10.1007/s00590-013-1284-0. Epub 2013 Aug 6.
Results Reference
background
PubMed Identifier
9113547
Citation
Ovadia D, Luger E, Bickels J, Menachem A, Dekel S. Efficacy of closed wound drainage after total joint arthroplasty. A prospective randomized study. J Arthroplasty. 1997 Apr;12(3):317-21. doi: 10.1016/s0883-5403(97)90029-2.
Results Reference
background
PubMed Identifier
19056215
Citation
Strahovnik A, Fokter SK, Kotnik M. Comparison of drainage techniques on prolonged serous drainage after total hip arthroplasty. J Arthroplasty. 2010 Feb;25(2):244-8. doi: 10.1016/j.arth.2008.08.014. Epub 2008 Dec 4.
Results Reference
background
PubMed Identifier
3403607
Citation
Willett KM, Simmons CD, Bentley G. The effect of suction drains after total hip replacement. J Bone Joint Surg Br. 1988 Aug;70(4):607-10. doi: 10.1302/0301-620X.70B4.3403607.
Results Reference
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Is Drainage Necessary After Total Hip Replacement?
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