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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT06628050
Eligibility Criteria:
Inclusion Criteria:
* Male or female over 18 years of age.
* Patient, or if applicable, his or her guardian or legal representative, willing to give informed consent.
* Clinically indicated for first intention total knee replacement.
* Geographically stable and willing to return for all follow-up visits or, at a minimum, to complete the patient self-report score.
Exclusion Criteria:
* Vulnerable subject (as defined in ISO-14155)
* Acute or chronic, local or systemic infection,
* Muscular, ligamental, neurological, psychological or vascular deficits,
* Bone destruction or poor bone quality likely to affect implant stability.
* Any concomitant condition likely to affect implant integration or function,
* Allergy or hypersensitivity to any of the materials used,
* For devices in CoCr Mo (ISO 5832/4): renal and hepatic impairment,
* Hip Knee Ankle (HKA) angle \< 165° or \> 195°,
* Severe collateral ligament deficiency (requiring a more constrained prosthesis),
* Major anatomical deformities,
* Severe flexion contracture or severe recurvatum,
* Revision of a partial or total knee prosthesis,
* Non-extractible material (e.g., screw, plate, intramedullary nail, osteosynthesis material) which can create a conflict with any component of the prosthesis,
* Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness,
* Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert),
* Bone degradation requiring an anchoring stem for femoral component
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06628050
Study Brief:
Protocol Section:
NCT06628050