Closed Suction Drainage After Revision Hip Arthroplasty

Study Overview
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Brief Summary
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Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after surgery.

Detailed Description
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Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. At the end of operation information of drainage was get out from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was taken on 3rd day after surgery and Harris Hip Score 6 weeks after.

Official Title
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Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study

Conditions
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Hip Osteoarthritis, Bleeding

Intervention / Treatment
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* Procedure: Drainage
* Procedure: No-drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aseptic loosening, head or insert damage, girdlestone hip Exclusion Criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drainage group<br>Patients with drainage after hip revision arthroplasty | Procedure: Drainage<br>* Use of the suction drainage after hip revision arthroplasty<br>|
| Active Comparator: No-drainage group<br>Patients without drainage after hip revision arthroplasty | Procedure: No-drainage<br>* Patients without drainage after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma size | Level of fluid at endoprosthesis neck in ultrasonography | 3 days after surgery | 
| Hemoglobin level | Hemoglobin level after surgery on 1st and 3rd day after surgery | 3 days after surgery | 
| Blood loss | Assessing blood loss with use of Gross formula | 1 day after surgery | 
| Reinfection | Number of patients with infection after surgery performed in the study | 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue hematoma | Note hematoma formation in soft tissue after surgery (ultrasonography) | 3 days after surgery | 
| C-reactive protein level | Level of C-reactive protein after surgery | 3 days after surgery | 
| Blood transfusion | Number of patients who need blood transfusion after surgery | 5-14 days after surgery | 
| Visual Analog Scale | Level of pain after surgery, 1- no pain; 10- the worst pain you ever had | 3 days after surgery | 
| Harris Hip Score | Clinical outcome after surgery, 0-100 points; 100 points the best score | 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Revision, Arthroplasty, Drainage