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NCT Number: NCT04333264

Clinical Analysis of Suction Drainage in Cementless Hip Replacement

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.

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Key information

Conditions

Arthropathy of Hip

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

suction drainage

Procedure

After primary total hip arthroplasty closed suction drainage will be used.

no suction drainage

Procedure

After primary total hip arthroplasty closed suction drainage won't be used.

Primary outcomes

  1. Hip hematoma size in USG

    Time frame: 3 days after surgery

    Size in millimeters fluid collection in supine position above femoral neck.

  2. Hemoglobin levels

    Time frame: 3 days after surgery

    Hb levels after surgery, difference between two groups

  3. C-reactive protein levels

    Time frame: 3 days after surgery

    C-reactive protein levels after surgery, difference between two groups

  4. Visual Analog Scale punctation

    Time frame: 3 day after surgery

    Pain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful.

  5. Hip range of movement

    Time frame: 3 days after surgery

    Differences between hip ROM after surgery

  6. Wound exudation

    Time frame: 3 days after surgery

    Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing

  7. Soft tissue hematoma

    Time frame: 3 days after surgery

    USG hematoma appearance in soft tissue around the hip

  8. Intraoperative bleeding

    Time frame: 1 day

    All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.

  9. Blood transfusion

    Time frame: 14 days after surgery

    Need of blood transfusion after operation

Secondary outcomes

  1. Infection

    Time frame: 30 days after surgery

    Superficial or deep infection after surgery

  2. Deep vein thrombosis

    Time frame: 30 days after surgery

    Occurrence lower limb thrombosis after surgery

  3. Readmission

    Time frame: 30 days after surgery

    Need to readmission after surgery

Sponsors and collaborators

Lead sponsor

Bartosz Paweł

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2020
Registry last updated
Apr 3, 2020

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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