Clinical Analysis of Suction Drainage in Cementless Hip Replacement

Arthropathy of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333264
• Other study ID #: 1/032016
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: Prof A Gruca Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Joint Diseases

Intervention

Procedure:
• suction drainage
After primary total hip arthroplasty closed suction drainage will be used.
• no suction drainage
After primary total hip arthroplasty closed suction drainage won't be used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bartosz Pawel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip hematoma size in USG	Size in millimeters fluid collection in supine position above femoral neck.	3 days after surgery
Primary	Hemoglobin levels	Hb levels after surgery, difference between two groups	3 days after surgery
Primary	C-reactive protein levels	C-reactive protein levels after surgery, difference between two groups	3 days after surgery
Primary	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
Primary	Hip range of movement	Differences between hip ROM after surgery	3 days after surgery
Primary	Wound exudation	Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing	3 days after surgery
Primary	Soft tissue hematoma	USG hematoma appearance in soft tissue around the hip	3 days after surgery
Primary	Intraoperative bleeding	All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.	1 day
Primary	Blood transfusion	Need of blood transfusion after operation	14 days after surgery
Secondary	Infection	Superficial or deep infection after surgery	30 days after surgery
Secondary	Deep vein thrombosis	Occurrence lower limb thrombosis after surgery	30 days after surgery
Secondary	Readmission	Need to readmission after surgery	30 days after surgery