Is Drainage Necessary After Total Hip Replacement?

Osteoarthritis, Hip Clinical Trial

Official title:

Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562586
• Other study ID #: CEP 1055
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: September 28, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• Closed Suction Drainage System
patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure

Locations

Country	Name	City	State
Brazil	Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. Review. — View Citation

González 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogue Scale for Pain	Scores range from 0 (no pain) to 10 (worst possible pain)	Pre-operative and 24 Hours Postoperative	No
Other	Harris Hip Score Questionnaire	<70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent	Pre-operative and 3 Months Postoperative	Yes
Primary	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	Yes
Secondary	Mid thigh circumference (cm)	Metric tape is placed midway between upper border of patella and superior anterior iliac spine	Pre-operative and 24 Hours Postoperative to 3 Months Postoperative	No
Secondary	C-Reactive Protein (CRP) (mg/L)		3,6 and 12 Weeks Postoperative	No
Secondary	Erythrocyte sedimentation rate (ESR) (mm/h)		3,6 and 12 Weeks Postoperative	No
Secondary	Complications		during 3 months follow-up	Yes