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Completed

NCT Number: NCT04486040

Closed Suction Drainage After Revision Hip Arthroplasty

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Bleeding Hemorrhage Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drainage

Procedure

Use of the suction drainage after hip revision arthroplasty

No-drainage

Procedure

Patients without drainage after surgery

Primary outcomes

  1. Hematoma size

    Time frame: 3 days after surgery

    Level of fluid at endoprosthesis neck in ultrasonography

  2. Hemoglobin level

    Time frame: 3 days after surgery

    Hemoglobin level after surgery on 1st and 3rd day after surgery

  3. Blood loss

    Time frame: 1 day after surgery

    Assessing blood loss with use of Gross formula

  4. Reinfection

    Time frame: 2 years after surgery

    Number of patients with infection after surgery performed in the study

Secondary outcomes

  1. Soft tissue hematoma

    Time frame: 3 days after surgery

    Note hematoma formation in soft tissue after surgery (ultrasonography)

  2. C-reactive protein level

    Time frame: 3 days after surgery

    Level of C-reactive protein after surgery

  3. Blood transfusion

    Time frame: 5-14 days after surgery

    Number of patients who need blood transfusion after surgery

  4. Visual Analog Scale

    Time frame: 3 days after surgery

    Level of pain after surgery, 1- no pain; 10- "the worst pain you ever had"

  5. Harris Hip Score

    Time frame: 6 weeks after surgery

    Clinical outcome after surgery, 0-100 points; 100 points the best score

Sponsors and collaborators

Lead sponsor

Prof A Gruca Teaching Hospital

Other

Registry information

Official study title

Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jul 24, 2020
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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