The use of Fibrin sealant In total knee Replacement Surgery Trial. A prospective randomised multicentre study.

The use of Fibrin sealant In total knee Replacement Surgery Trial. A prospective randomised multicentre study. - FIRST study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38022

Enrollment

500

Registered

2010-09-15

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis total knee replacement

Interventions

The intervention is the application of CryoSeal during surgery according to the standardised manner. The control group will receive standard care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - planned for elective primary total knee replacement - older than 18 years - ASA classification I-III

Exclusion criteria

Exclusion criteria: - liver failure - coagulation disorder - patients with known hemophilie or von Willibrand disease - patients with INR >2

Design outcomes

Primary

Measure	Time frame
Difference in extension angel pre-operatively and 2 (and 6) weeks after surgery	—

Secondary

Measure	Time frame
Secondary endpoints: postoperative complications, VAS pain score, knee function Flexion/Extension, Barthel score (day 3); Outpatient department scores (2 weeks, 6 weeks and 3 months, 1 year): Complications, VAS pain knee function, KSS, KOOS, SF-12, IPQ-K and EQ5D	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)