Closed Suction Drainage After Revision Hip Arthroplasty

August 2, 2021 updated by: Bartosz Paweł, Prof A Gruca Teaching Hospital

Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drainage group
Patients with drainage after hip revision arthroplasty
Use of the suction drainage after hip revision arthroplasty
Active Comparator: No-drainage group
Patients without drainage after hip revision arthroplasty
Patients without drainage after surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pawel Bartosz, Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Actual)

March 13, 2018

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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