Trial document




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  DRKS00007564

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In several surgical disciplines, fibrin sealants are used in order to improve haemostasis in cases in which traditional measures are insufficient.
This study is conducted in order to determine the benefit of using the fibrin sealant EVICEL during implantation of an artificial knee joint.
The primary outcome parameter is the blood loss, determined as the decrease of the red blood pigment haemoglobin.
68 patients are included undergoing the standard operative procedure. EVICEL is only applied in the interventional group in addition to conventional measures of haemostasis.

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Brief Summary in Scientific Language

This study is designed to determine the efficacy of the fibrin sealant EVICEL® in patients undergoing total knee replacement (TKR). 68 patients scheduled for TKR are randomized and undergo surgery in a standard technique. Those patients randomized in the interventional group receive the fibrin sealant EVICEL in addition to the conventional measures of haemostasis.
The primary objective is to show the superiority of EVICEL® for controlling haemostasis and reducing post operative blood loss in patients undergoing TKR compared with the use of standard orthopaedic surgery. The secondary objective is to show that EVICEL® reduces the need for transfusions and increases range of motion, measured 7 days after surgery and in the long term, improves wound healing and reduces the need for analgesics. In addition, two clinical outcome scores will be assessed. A further objective is to show that EVICEL® application reduces the overall costs of TKR treatment.

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Organizational Data

  •   DRKS00007564
  •   2014/11/26
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  •   yes
  •   Approved
  •   6170M mono, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   2010-024376-25 
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Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
  •   D62 -  Acute posthaemorrhagic anaemia
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Interventions/Observational Groups

  •   Control intervention:
    Thirty-four (34) control patients will receive the MHH (Hannover Medical School) standard orthopedic surgery treatment (total knee replacement) with standard measures of haemostasis (electrocoagulation).
  •   Experimental intervention:
    Thirty four (34) patients will receive the same treatment as control patients plus 5 ml EVICEL® applied during surgery according to the manufacturer's guidelines.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, assessor
  •   Active control
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

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

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Secondary Outcome

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).
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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/06/01
  •   68
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   70   Years
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Additional 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.

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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.

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hochschule Hannover im Annastift
    • Mr.  Dr. med.  Stefan  Budde 
    • Anna-von-Borries-Str. 1-7
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hochschule Hannover im Annastift
    • Mr.  Dr.  Stefan  Budde 
    • Anna-von-Borries-Str. 1-7
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Ethicon (division of JOHNSON & JOHNSON MEDICAL LIMITED)
    • PO Box 1988, Simpson Parkway, Kirkton Campus
    • EH54 0AB  Livingston
    • United Kingdom
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Status

  •   Recruiting withdrawn before recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.