The use of Fibrin Sealant in total knee replacement surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24264

Enrollment

500

Registered

2010-09-09

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

TKR, Cryoseal, fibrin, rehabilitation

Interventions

The CryoSeal (CS) experimental product consists of two components: cryoprecipitate and thrombin. Cryoprecipitate is one fraction of a single human plasma donation that contains concentrated coagulatio

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who will undergo primary total knee replacement surgery for osteoarthritis or rheumatic arthritis; 2. Age, minimum of 18 years; 3. (Admission of the patient after informed consent); 4. ASA classification I-III.

Exclusion criteria

Exclusion criteria: 1. Liver failure; 2. Congenital or acquired coagulation disorders; 3. Patients with known haemophilia or von Willibrand disease; 4. Patients with INR >2 (standard practice for operation).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Postoperative Hb/Ht; 2. Number of transfusions after surgery; 3. VAS pain score; 4. Complications; 5. Total hospital stay and duration of rehabilitation; 6. Illness perception IPQ-K score; 7. Function improvement score (KSS, Barthel Index score, KOOS); 8. Postoperative F/E.	—

Contacts

Public ContactW.Chr. Verra

PO Box 9600, Postzone J-11-R

w.c.verra@lumc.nl+31 (0)71 5261566

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)