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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT05893602
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria: The patient
1. is 18 years of age or older
2. receives a MUTARS knee replacement with PEEK HD coupling mechanism, or undergoes a revision (for any reason) of a MUTARS knee replacement during which the MoM coupling mechanism is revised for a PEEK HD coupling mechanism
3. Is able to give informed consent
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Anamnestic use of metal containing nutritional supplements or medications
2. Contact with metal ions in the work environment
3. Renal insufficiency defined as an eGFR\<60
4. Presence of implants containing Cobalt and Chrome (including non-orthopaedic implants such as stents and dental implants)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05893602
Study Brief:
Protocol Section:
NCT05893602