The use of Fibrin sealant In total knee Replacement Surgery Trial. A prospective randomised multicentre study.
Completed
- Conditions
- osteoarthritistotal knee replacement10023213
- Registration Number
- NL-OMON38022
- Lead Sponsor
- Sanquin Bloedbank
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
- planned for elective primary total knee replacement
- older than 18 years
- ASA classification I-III
Exclusion Criteria
- liver failure
- coagulation disorder
- patients with known hemophilie or von Willibrand disease
- patients with INR >2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in extension angel pre-operatively and 2 (and 6) weeks after surgery</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: postoperative complications, VAS pain score, knee function<br /><br>Flexion/Extension, Barthel score (day 3); Outpatient department scores (2<br /><br>weeks, 6 weeks and 3 months, 1 year): Complications, VAS pain knee function,<br /><br>KSS, KOOS, SF-12, IPQ-K and EQ5D </p><br>