Is Drainage Necessary After Total Hip Replacement?

NCT ID: NCT02562586

Last Updated: 2015-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Closed Suction Drainage System

Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure

Group Type ACTIVE_COMPARATOR

Closed Suction Drainage System

Intervention Type DEVICE

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

No Closed Suction Drainage System

Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Closed Suction Drainage System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jose Ricardo Negreiros Vicente

Head of Hip Surgery Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Ricardo Negreiros Vicente, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 23982636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15022802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23917702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9113547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19056215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3403607 (View on PubMed)

Other Identifiers

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CEP 1055

Identifier Type: -

Identifier Source: org_study_id

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