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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03056534
Eligibility Criteria:
Inclusion Criteria:
* Patient is 18-75 years old and he/she is skeletally mature
* Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
* Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires
* Patient has consented to participating in the study by signing the IRB/EC approved informed consent form
Exclusion Criteria:
* Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
* Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint
* Patients with active joint infections or chronic systemic infection
* Obese patients where obesity is defined as BMI ≥ 40
* Skeletal immaturity
* Known allergy to implant materials
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03056534
Study Brief:
Protocol Section:
NCT03056534