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Closed Suction Drainage After Revision Hip Arthroplasty

Primary Purpose

Hip Osteoarthritis, Bleeding

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drainage
No-drainage
Sponsored by
Prof A Gruca Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Hip, Revision, Arthroplasty, Drainage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Drainage group

    No-drainage group

    Arm Description

    Patients with drainage after hip revision arthroplasty

    Patients without drainage after hip revision arthroplasty

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 22, 2020
    Last Updated
    August 2, 2021
    Sponsor
    Prof A Gruca Teaching Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04486040
    Brief Title
    Closed Suction Drainage After Revision Hip Arthroplasty
    Official Title
    Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 14, 2016 (Actual)
    Primary Completion Date
    March 13, 2018 (Actual)
    Study Completion Date
    March 13, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Prof A Gruca Teaching Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis, Bleeding
    Keywords
    Hip, Revision, Arthroplasty, Drainage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drainage group
    Arm Type
    Active Comparator
    Arm Description
    Patients with drainage after hip revision arthroplasty
    Arm Title
    No-drainage group
    Arm Type
    Active Comparator
    Arm Description
    Patients without drainage after hip revision arthroplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Drainage
    Intervention Description
    Use of the suction drainage after hip revision arthroplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    No-drainage
    Intervention Description
    Patients without drainage after surgery
    Primary Outcome Measure Information:
    Title
    Hematoma size
    Description
    Level of fluid at endoprosthesis neck in ultrasonography
    Time Frame
    3 days after surgery
    Title
    Hemoglobin level
    Description
    Hemoglobin level after surgery on 1st and 3rd day after surgery
    Time Frame
    3 days after surgery
    Title
    Blood loss
    Description
    Assessing blood loss with use of Gross formula
    Time Frame
    1 day after surgery
    Title
    Reinfection
    Description
    Number of patients with infection after surgery performed in the study
    Time Frame
    2 years after surgery
    Secondary Outcome Measure Information:
    Title
    Soft tissue hematoma
    Description
    Note hematoma formation in soft tissue after surgery (ultrasonography)
    Time Frame
    3 days after surgery
    Title
    C-reactive protein level
    Description
    Level of C-reactive protein after surgery
    Time Frame
    3 days after surgery
    Title
    Blood transfusion
    Description
    Number of patients who need blood transfusion after surgery
    Time Frame
    5-14 days after surgery
    Title
    Visual Analog Scale
    Description
    Level of pain after surgery, 1- no pain; 10- "the worst pain you ever had"
    Time Frame
    3 days after surgery
    Title
    Harris Hip Score
    Description
    Clinical outcome after surgery, 0-100 points; 100 points the best score
    Time Frame
    6 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pawel Bartosz
    Organizational Affiliation
    Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Closed Suction Drainage After Revision Hip Arthroplasty

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