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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT05607966
Eligibility Criteria:
Inclusion Criteria:
* Male and female over 18 years of age
* Each patient who is willing to give informed consent.
* Clinically indicated for a total knee replacement
* Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
* Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.
Exclusion Criteria:
* 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 (requiring a femoral and/or a tibial stem and/or a thick insert)
* Any concomitant condition likely to affect implant integration or function
* Allergy or hypersensitivity to any of the materials used
* For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
* Hip Knee Ankle (HKA) angle \< 165° or \> 195°
* Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
* Posterior cruciate ligament deficiency
* Major anatomical deformities
* Severe flexion contracture or severe recurvatum
* Revision of a partial or total knee prosthesis
* Non-extractible material (e.g. screws, 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:
NCT05607966
Study Brief:
Protocol Section:
NCT05607966