Clinical trial NCT02562586: Is Drainage Necessary After Total Hip Replacement?
Official title: Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Suction
Arthroplasty
Replacement
Hip
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline red blood cells (RBC)
timeFrame: Pre-operative and 24 Hours Postoperative
Secondary outcomes:
measure: Mid thigh circumference (cm)
timeFrame: Pre-operative and 24 Hours Postoperative to 3 Months Postoperative
measure: C-Reactive Protein (CRP) (mg/L)
timeFrame: 3,6 and 12 Weeks Postoperative
measure: Erythrocyte sedimentation rate (ESR) (mm/h)
timeFrame: 3,6 and 12 Weeks Postoperative
measure: Complications
timeFrame: during 3 months follow-up
Other outcomes:
measure: Visual Analogue Scale for Pain
timeFrame: Pre-operative and 24 Hours Postoperative
measure: Harris Hip Score Questionnaire
timeFrame: Pre-operative and 3 Months Postoperative
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
state: SP
Study officials:
affiliation: Hip Surgery Group Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
name: Jose Ricardo Negreiros Vicente, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.