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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT06670651
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older, and skeletally mature; and
* Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care.
* Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages).
Exclusion Criteria:
* 80 years of age or older,
* Women who are pregnant at the time of surgery,
* History of joint sepsis,
* Bone defect that requires grafting,
* Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation,
* Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation,
* A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT06670651
Study Brief:
Protocol Section:
NCT06670651