Clinical Analysis of Suction Drainage in Cementless Hip Replacement

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

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.

Study Overview

• Status: Completed
• Conditions: Arthropathy of Hip
• Intervention / Treatment: Procedure: suction drainage; Procedure: no suction drainage

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bartosz Paweł
• Investigators: Principal Investigator: Pawel Bartosz, Prof. A. Gruca Teaching Hospital in Otwock

Publications and helpful links

General Publications

• Bartosz P, Marczynski W, Para M, Kogut M, Bialecki J. Comparative study of suction drainage placement in cementless hip replacement among patients undergoing extended thromboprophylaxis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 13;22(1):688. doi: 10.1186/s12891-021-04583-0.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: arthroplasty; drainage; hip; suction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 1/032016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No