M17.1 D62
Conditions
Interventions
Group 1: 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
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
55 Years to 70 Years
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the Hb level difference baseline minus the detected minimum in the first seven days post OP. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactStefan Budde
Orthopädische Klinik der Medizinischen Hochschule Hannover im Annastift
Outcome results
None listed