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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT04255394
Eligibility Criteria:
Inclusion Criteria:
* Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program
* Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form"
* Age: =\> 18 years
* Male and Female
* Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis \& post traumatic arthritis
* Rheumatoid arthritis,
* Correction of functional deformity
* Revision of failed joint reconstruction or treatment
* Treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques
Exclusion Criteria:
* Infection, sepsis, and osteomyelitis
* Patients who are unwilling or unable to give consent, or to comply with the follow-up program
* The patient is known to be pregnant or breastfeeding
* Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate)
* Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction
* Osteoporosis
* Metabolic disorder which may impair bone formation
* Osteomalacia
* Local and distant foci of infection
* Rapid joint destruction, marked bone loss or bone resorption apparent on roent-genogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease
* Skeletal immaturity
* Morbid obesity
* Foreign body sensitivity. Where suspected, material sensitivity tests are to be made prior to implantation
* Any condition that may interfere with the survival of the implant such as Paget's disease, Charcot's disease, sickle cell anaemia or traits, lower extremity muscular atrophy or neuromuscular disease'
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04255394
Study Brief:
Protocol Section:
NCT04255394