Closed Suction Drainage After Revision Hip Arthroplasty

Bleeding Clinical Trial

Official title:

Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486040
• Other study ID #: GrucaTH
• Status: Completed
• Phase: N/A
• Start date: March 14, 2016
• Est. completion date: March 13, 2020

Study information

• Verified date: August 2021
• Source: Prof A Gruca Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Drainage
Use of the suction drainage after hip revision arthroplasty
• No-drainage
Patients without drainage after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof A Gruca Teaching Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma size	Level of fluid at endoprosthesis neck in ultrasonography	3 days after surgery
Primary	Hemoglobin level	Hemoglobin level after surgery on 1st and 3rd day after surgery	3 days after surgery
Primary	Blood loss	Assessing blood loss with use of Gross formula	1 day after surgery
Primary	Reinfection	Number of patients with infection after surgery performed in the study	2 years after surgery
Secondary	Soft tissue hematoma	Note hematoma formation in soft tissue after surgery (ultrasonography)	3 days after surgery
Secondary	C-reactive protein level	Level of C-reactive protein after surgery	3 days after surgery
Secondary	Blood transfusion	Number of patients who need blood transfusion after surgery	5-14 days after surgery
Secondary	Visual Analog Scale	Level of pain after surgery, 1- no pain; 10- "the worst pain you ever had"	3 days after surgery
Secondary	Harris Hip Score	Clinical outcome after surgery, 0-100 points; 100 points the best score	6 weeks after surgery