Is Drainage Necessary After Total Hip Replacement?

NCT02562586 | Completed

• 1 other identifier: CEP 1055
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Keywords

Suction; Arthroplasty; Replacement; Hip

Outcome Measures

Primary Outcomes (1)

• 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

  Pre-operative and 24 Hours Postoperative

Secondary Outcomes (4)

• Mid thigh circumference (cm)

  Pre-operative and 24 Hours Postoperative to 3 Months Postoperative

• C-Reactive Protein (CRP) (mg/L)

  3,6 and 12 Weeks Postoperative

• Erythrocyte sedimentation rate (ESR) (mm/h)

  3,6 and 12 Weeks Postoperative

• Complications

  during 3 months follow-up

Other Outcomes (2)

• Visual Analogue Scale for Pain

  Pre-operative and 24 Hours Postoperative

• Harris Hip Score Questionnaire

  Pre-operative and 3 Months Postoperative

Study Arms (2)

Closed Suction Drainage System

ACTIVE COMPARATOR

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

No Closed Suction Drainage System

NO INTERVENTION

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

Interventions

Closed Suction Drainage System DEVICE

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

Closed Suction Drainage System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Hip Arthroplasty
• Lateral Hardinge Approach
• Non-cemented Acetabular and Femoral Components
• Length of Skin Incision between 10 and 20 cm

You may not qualify if:

• Coagulative Disorders
• Previous Surgery in the same limb
• Age below 18 years old

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (6)

• 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.

  PMID: 23982636 BACKGROUND

• 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.

  PMID: 15022802 BACKGROUND

• 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.

  PMID: 23917702 BACKGROUND

• 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.

  PMID: 9113547 BACKGROUND

• 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.

  PMID: 19056215 BACKGROUND

• 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.

  PMID: 3403607 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hip Surgery Group

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: September 29, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

BR (1)