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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Skovgaard Nielsen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01472913
First received: October 11, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Blood Loss
Drug: Fibrin sealant
Drug: Saline water
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Blood loss [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    24 hours postopertive blood loss estimated by drains from each of the knees .


Secondary Outcome Measures:
  • Pain [ Time Frame: 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day. ] [ Designated as safety issue: No ]

    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.


  • swelling [ Time Frame: 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day ] [ Designated as safety issue: No ]

    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.


  • Range of Movement (ROM) [ Time Frame: 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day ] [ Designated as safety issue: No ]

    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.


  • Strength [ Time Frame: 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day ] [ Designated as safety issue: No ]

    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.



Enrollment: 48
Study Start Date: August 2010
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fibrin Sealent Drug: Fibrin sealant
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 Name: Evicel, ATC-kode B02BC30
Placebo Comparator: Saline water Drug: Saline water
Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472913

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Christian Skovgaard Nielsen, M.D Hvidovre University Hospital
Principal Investigator: Henrik Husted, M.D. Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Christian Skovgaard Nielsen, M.D. Orthopedic Surgery, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01472913     History of Changes
Other Study ID Numbers: H-A-2009-69
Study First Received: October 11, 2011
Last Updated: April 14, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
Prospective randomised double-blind study
Fibrin sealant
Bilateral simultaneous total knee arthroplasty
Blood loss
Postoperative pain

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014