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:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01461356
Eligibility Criteria:
Inclusion Criteria:
* Primary arthroplasty
* Age between 45 and 75 years old
* Single condylar implant design
Exclusion Criteria:
* Revision arthroplasty
* Age less than 45 and greater than 75 years old
* Pre-operative flexion lower than 90 degrees
* Valgus or varus knee deformity greater than 15 degrees.
* The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal disease, hepatitis) or metastasis disease.
* Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing.
* Any congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with TK prosthesis survival or success.
* Presence of previous prosthetic knee or hip replacement device.
* BMI \> 30.
* Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01461356
Study Brief:
Protocol Section:
NCT01461356