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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT04348968
Eligibility Criteria:
Inclusion Criteria:
* Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm.
* The Zimmer Maxera Cup is indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis, congenital hip dysplasia, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
Exclusion Criteria:
* Active, old, or remote infection of the hip.
* Osteoradionecrosis.
* Local bone tumors and/or cysts.
* Patients with poor bone quality, where there is inadequate bone to support the implant(s).
* Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
* Allergy to the implanted material.
* Patient's physical conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, e.g. previous surgery, insufficient quality or quantity of bone resulting from conditions such as cancer or congenital dislocation, metabolic bone disease of the upper femur or pelvis, femoral osteotomy revision, girdle stone revision, osteoporosis, osteomyelitis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures, joint neuropathy) or other conditions that may lead to inadequate skeletal fixation
* Do not use ceramic femoral heads which are not BIOLOX delta or BIOLOX OPTION with Maxera components.
* Use of this device when a less invasive procedure would be sufficient.
* Skeletal immaturity.
* Any nerve or muscle disease that may have a negative effect on gait or weight bearing
* Loss of abductor musculature in the affected limb.
* Poor skin coverage around the hip joint.
* Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04348968
Study Brief:
Protocol Section:
NCT04348968