Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00161902
Eligibility Criteria:
Inclusion Criteria:
Each subject to be included into the study must fulfill the following inclusion criteria:
* Subjects receiving a cement free hip prosthesis due to coxarthrosis because of primary or dysplastic arthrosis grade 1 - 3 according to Crowe or rheumatoid arthritis as well as subjects receiving a cement free hip prosthesis due to femur head necrosis (Crowe classification).
* ASA and NSAIDs have been discontinued one week prior to surgery
* Written informed consent
* Male and female at least 19 years of age
Exclusion Criteria:
Subjects fulfilling the following exclusion criteria will not be recruited into the study:
* Impaired coagulation
* Previous hip surgery
* Acetabular roof plastic
* Known hypersensitivity to aprotinin or other components of the product
* Immunodeficiency
* Increased red cell production
* Pregnant or lactating women (positive urine or serum pregnancy test; this test is required of any female subject who is not post menopausal or surgically sterilized).
* Subjects concurrently participating in another clinical trial or having received another investigational drug within the last 30 days.
Also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00161902
Study Brief:
Protocol Section:
NCT00161902