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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02756702
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
* degenerative osteoarthritis;
* rheumatoid arthritis;
* posttraumatic arthritis;
* symptomatic knee instability;
* knee stiffness or deformation of the knee joint;
* Age ≥ 18 years;
* Patient signed informed consent
Exclusion Criteria:
* Age younger than 18 years
* Any prior joint replacement at the index knee
* Unable or unwilling to return for postoperative follow-up
* Patient did not sign informed consent
* Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
* Acute or chronic infections near the joint, or systemic infections
* Secondary diseases that could influence joint implant functionality
* Systemic diseases and metabolic disorders
* Severe osteoporosis or osteomalacia
* Severely damaged bone structures that could prevent stable implantation of implant components
* Bone tumors in the region of implant fixation
* Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
* Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
* Dependency on pharmaceutical drugs, drug abuse, or alcoholism
* Fever, infection or inflammation (systemic or local)
* Pregnancy
* Mental illness
* Severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants
* Combination with implant components from other manufacturers
* Inadequate patient compliance
* Foreign body sensitivity to the implant materials
* All cases not listed under indications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02756702
Study Brief:
Protocol Section:
NCT02756702