The use of Fibrin Sealant in total knee replacement surgery.
Completed
- Conditions
- TKR, Cryoseal, fibrin, rehabilitation
- Registration Number
- NL-OMON24264
- Lead Sponsor
- Sanquin blood bank, Leiden
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
1. Patients who will undergo primary total knee replacement surgery for osteoarthritis or rheumatic arthritis;
2. Age, minimum of 18 years;
Exclusion Criteria
1. Liver failure;
2. Congenital or acquired coagulation disorders;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative knee function in mean extension difference with goniometric at 2 and 6 weeks (in relation to secondary endpoints), corrected for pre-operative extension.
- Secondary Outcome Measures
Name Time Method 1. Postoperative Hb/Ht;<br /><br>2. Number of transfusions after surgery;<br /><br>3. VAS pain score;<br /><br>4. Complications;<br /><br>5. Total hospital stay and duration of rehabilitation;<br /><br>6. Illness perception IPQ-K score;<br /><br>7. Function improvement score (KSS, Barthel Index score, KOOS);<br /><br>8. Postoperative F/E.