- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486040
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GrucaTH
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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