Is the application of CryoSeal (CS) in primary total knee replacement surgery beneficial for the patient with respect to a faster track and improved postoperative rehabilitation. The beneficial effect may be due to quicker functional knee…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in extension angel pre-operatively and 2 (and 6) weeks after surgery
Secondary outcome
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
Background summary
Fibrin Sealant is known to have some potential benefits for intraoperative use,
especially in the acceleration of the coagulation cascade. Most studies with
fibrin glue are focussing on the reduction of allogeneic blood transfusion and
the possibilities to reduce costs. Firstly, fibrin sealant was made from
patients* blood plasma but the logistic problems made introduction in general
hard. Now Sanquin has produced a CryoSeal (fibrin sealant) made of single-donor
plasma which can be used during surgery. This application is already used in
cardiothoracic surgery.
Study objective
Is the application of CryoSeal (CS) in primary total knee replacement surgery
beneficial for the patient with respect to a faster track and improved
postoperative rehabilitation. The beneficial effect may be due to quicker
functional knee rehabilitation, by pain reduction, better mobilisation and
improved quality of life during the early postoperative period.
Study design
Randomised controlled trial stratified by clinic.
Intervention
The intervention is the application of CryoSeal during surgery according to the
standardised manner. The control group will receive standard care.
Study burden and risks
Given the origin of the CryoSeal product, i.e. donor plasma and in the absence
of added bovine or chemical fibrinolysis inhibitors, no toxicity is to be
expected by applying CryoSeal produced by the CS-1 (machine) / CP-3
(disposable) system, which was confirmed by pre and clinical research.
Plesmanlaan 1a
LEIDEN 2333 BZ
NL
Plesmanlaan 1a
LEIDEN 2333 BZ
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL32594.058.10 |