Clinical Analysis of Suction Drainage in Cementless Hip Replacement

Study Overview
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Brief Summary
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Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.

Official Title
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Clinical Analysis of Suction Drainage in Cementless Hip Replacement - a Prospective Randomized Study

Conditions
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Arthropathy of Hip

Intervention / Treatment
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* Procedure: suction drainage
* Procedure: no suction drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 30-80 primary hip osteoarthritis Exclusion Criteria: secondary hip osteoarthritis autoimmune disease congenital or secondary coagulopathy vein or artery thrombosis renal or liver failure cemented or hybrid alloplasty, no consent from the patient

Ages Eligible for Study
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Minimum Age: 30 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
Interventional Model Description: Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: suction drainage<br>Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty | Procedure: suction drainage<br>* After primary total hip arthroplasty closed suction drainage will be used.<br>|
| Active Comparator: no suction drainage<br>Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty | Procedure: no suction drainage<br>* After primary total hip arthroplasty closed suction drainage won't be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip hematoma size in USG | Size in millimeters fluid collection in supine position above femoral neck. | 3 days after surgery | 
| Hemoglobin levels | Hb levels after surgery, difference between two groups | 3 days after surgery | 
| C-reactive protein levels | C-reactive protein levels after surgery, difference between two groups | 3 days after surgery | 
| Visual Analog Scale punctation | Pain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful. | 3 day after surgery | 
| Hip range of movement | Differences between hip ROM after surgery | 3 days after surgery | 
| Wound exudation | Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing | 3 days after surgery | 
| Soft tissue hematoma | USG hematoma appearance in soft tissue around the hip | 3 days after surgery | 
| Intraoperative bleeding | All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula. | 1 day | 
| Blood transfusion | Need of blood transfusion after operation | 14 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Superficial or deep infection after surgery | 30 days after surgery | 
| Deep vein thrombosis | Occurrence lower limb thrombosis after surgery | 30 days after surgery | 
| Readmission | Need to readmission after surgery | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, arthroplasty, suction, drainage