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NCT Number: NCT01472913

Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength

The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.

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Key information

Conditions

Blood Loss Hemorrhage Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Hvidovre, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective bilateral knee arthroplasty
  • Must speak and understand Danish
  • Musk be able to gave oral and written consent.
  • Females must be post-menopausal, and last menstruation must be minimum of one year ago.

Exclusion criteria

  • Alcohol or medicine abuse
  • Treatment with opioids
  • Allergy to local anaesthetics
  • Allergy to active substances i fibrin sealant
  • Age below 18

Treatment and study plan

Fibrin Sealant

Drug

Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.

Other names: Evicel, ATC-kode B02BC30

Saline water

Drug

Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).

Primary outcomes

  1. Blood loss

    Time frame: 24 hours postoperative

    24 hours postopertive blood loss estimated by drains from each of the knees .

Secondary outcomes

  1. Pain

    Time frame: 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.

    2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist.

    Measurement of postoperative pain is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.

  2. swelling

    Time frame: 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day

    2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist.

    Measurement of postoperative swelling is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. The swelling is measured as the difference of circumference 1 cm proximal of the patella 2-3 weeks before surgery and at the outlined postoperative times.

  3. Range of Movement (ROM)

    Time frame: 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day

    2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist.

    Measurement of postoperative ROM is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.

  4. Strength

    Time frame: 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day

    2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist.

    Measurement of postoperative strength is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2011
Registry last updated
Apr 22, 2015

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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