Back to resultsFibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength
Primary Purpose
Blood Loss
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Fibrin sealant
Saline water
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss focused on measuring Prospective randomised double-blind study, Fibrin sealant, Bilateral simultaneous total knee arthroplasty, Blood loss, Postoperative pain, Complications
Eligibility 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
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fibrin Sealent
Saline water
Arm Description
Outcomes
Primary Outcome Measures
Blood loss
24 hours postopertive blood loss estimated by drains from each of the knees .
Secondary Outcome Measures
Pain
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
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)
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
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.
Full Information
NCT ID
NCT01472913
First Posted
October 11, 2011
Last Updated
April 20, 2015
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01472913
Brief Title
Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Prospective randomised double-blind study, Fibrin sealant, Bilateral simultaneous total knee arthroplasty, Blood loss, Postoperative pain, Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibrin Sealent
Arm Type
Active Comparator
Arm Title
Saline water
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fibrin sealant
Other Intervention Name(s)
Evicel, ATC-kode B02BC30
Intervention Description
Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.
Intervention Type
Drug
Intervention Name(s)
Saline water
Intervention Description
Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).
Primary Outcome Measure Information:
Title
Blood loss
Description
24 hours postopertive blood loss estimated by drains from each of the knees .
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.
Title
swelling
Description
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.
Time Frame
2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day
Title
Range of Movement (ROM)
Description
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.
Time Frame
2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day
Title
Strength
Description
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.
Time Frame
2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Skovgaard Nielsen, M.D
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Husted, M.D.
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength
We'll reach out to this number within 24 hrs