Closed Suction Drainage After Revision Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hip Osteoarthritis; Bleeding
• Interventions: Procedure: Drainage; Procedure: No-drainage

• Registration Number: NCT04486040
• Lead Sponsor: Prof A Gruca Teaching Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-14
• Primary Completion: 2018-03-13
• Study Completion: 2020-03-13
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drainage group	Drainage	Patients with drainage after hip revision arthroplasty
No-drainage group	No-drainage	Patients without drainage after hip revision arthroplasty

Primary Outcome Measures

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

Secondary Outcome Measures

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