Clinical Analysis of Suction Drainage in Cementless Hip Replacement

Not Applicable

Completed

• Conditions: Arthropathy of Hip
• Interventions: Procedure: suction drainage; Procedure: no suction drainage

• Registration Number: NCT04333264
• Lead Sponsor: Bartosz Paweł

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2020-01
• Study Completion: 2020-02
• Study First Submitted: 2020-03-30
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suction drainage	suction drainage	Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty
no suction drainage	no suction drainage	Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Deep vein thrombosis	30 days after surgery	Occurrence lower limb thrombosis after surgery
Infection	30 days after surgery	Superficial or deep infection after surgery
Readmission	30 days after surgery	Need to readmission after surgery