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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT05186168
Eligibility Criteria:
Inclusion Criteria:
* A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or developmental dysplasia of the hip.
* Avascular necrosis of the femoral head
* All subjects must be between the age of 18 and 75 at the time of surgery to take part in this study
* Scheduled for a primary total hip replacement.
Exclusion Criteria:
* Active infection
* Severe Obesity (BMI over 35)
* Pregnancy
* Mental illness
* Grossly distorted anatomy (surgeon's discretion)
* Sepsis
* Osteomyelitis
* Osteomalacia
* Distant foci of infections
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Muscular atrophy or neuromuscular disease
* Allergy to implant material
* Marked bone loss or bone resorption
* Patients without sufficient quantities of synovial fluid to allow for proper lubrication, such as patients with Sjogren's syndrome
* Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock or poor skin coverage around the hip joint which would make the procedure inappropriate
* Any case not described in the inclusion criteria
* Any patient who cannot or will not provide informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05186168
Study Brief:
Protocol Section:
NCT05186168