Is Drainage Necessary After Total Hip Replacement?

Study Overview
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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.

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

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: Closed Suction Drainage System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closed Suction Drainage System<br>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<br>* patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure<br>|
| No Intervention: No Closed Suction Drainage System<br>Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suction, Arthroplasty, Replacement, Hip