Randomized Controlled Trial to determine the efficacy of EVICEL® on blood loss in orthopaedic surgery after total knee replacement (TKR)

Phase 4

• Conditions: M17.1; Other primary gonarthrosis; D62; Acute posthaemorrhagic anaemia

• Registration Number: DRKS00007564
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Males or females aged from 55 to 70 years at the day of the operation.
2. Patients with the indication for primary TKR on the basis of diagnosed osteoarthritis, arthritis or avascular necrosis.
3. Patients with intact medial and lateral collateral ligaments (to be diagnosed in the preoperative examination) who are planned to receive a prosthesis of the Stryker Triathlon CR or Triathlon PS ® system in the preoperative planning.
4. Patients willing to participate in this randomized controlled trial (RCT) and having signed the informed consent approved by the ethics committee.

Exclusion Criteria

1. Patients participating in any other clinical trial within 30 days before inclusion or concurrent to this study.
2 Pregnant or nursing women
3. Patients tested positive for HIV, Hep B and C
4. Patients with documented or suspected hypersensitivity to any of the active substances or excipients of EVICEL® or to bone cement or its components.
5. Patients with acute or suspected coagulation disorders and patients with preoperative blood parameters INR>1,4 or PTT > 40 s.
6. Concomitant medication within 7 days before surgery with substances that affect haemostasis, except for low molecular weight heparins or alternatives in prophylactic dosage indicated for standard thrombosis prophylaxis.
7. Anemic patients showing preoperative Hb levels < 11 g/dl.
8. Patients with a deficit in extension of >15° or with a maximal flexion of less than 90°
9. Highly obese people (BMI>35).
10. Patients suffering from neuromuscular or neurosensoric diseases.
11. Patients with known active tumour disease or tumour related diseases.
12. Patients suffering from any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
13. Patients receiving a prosthesis different to the Stryker Triathlon CR or Triathlon PS system due to intraoperative circumstances (such as bone fractures or ligament insufficiencies)
14. Intraoperative deviation from the agreed haemostatic procedure (e.g. use of the
tourniquet deviant from the agreement, e. g. in case of surgery lasting more than 2 hours). Patients with surgery lasting more than two 2 hours will not be randomized.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the Hb level difference baseline minus the detected minimum in the first seven days post OP.

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with need for transfusions or use of own blood donation will be reported during the in-house treatment. The range of motion (parameter: angle of maximum flexion) and the clinical outcome (assessed by means of the clinical outcome scores KSS and KOOS) are determined at the follow-up examinations on day 7 and at 3, 6 and 12 months after surgery. The patients’ mobility (first day when walking on crutches is possible and ability to climb stairs) is documented daily during in-house treatment, as well as the use of analgetics (classified by the WHO pain ladder) or of a peripheral nerval block and the time point of wound healing (ceasing of postoperative wound secretion).<br>The length of stay in hospital in days after surgery will be assessed at the end of the in-house treatment. The overall costs of TKR will be calculated after 12 months.