Blood Loss
Conditions
Keywords
Prospective randomised double-blind study, Fibrin sealant, Bilateral simultaneous total knee arthroplasty, Blood loss, Postoperative pain, Complications
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.
Interventions
DRUGFibrin 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.
DRUGSaline water
Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | 24 hours postoperative | 24 hours postopertive blood loss estimated by drains from each of the knees . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 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. |
| swelling | 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. |
| Strength | 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. |
| Range of Movement (ROM) | 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. |
Countries
Denmark
Outcome results
None listed