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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02344160
Eligibility Criteria:
Inclusion Criteria:
* Subject requires revision hip arthroplasty
* Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant
* Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
* Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
* Endoprosthesis, femoral osteotomy, or Girdlestone resection
* Subject is at least 18 years of age
* Subject is skeletally mature in Investigators judgment
* Subject is willing to consent to participate in the study
* Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
Exclusion Criteria:
* Known allergies to any components of the devices
* Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
* Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
* Subject is facing current or impending incarceration
* Female subject is of child-bearing age and not using an approved method of contraception
* Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study
* Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.
* Skeletal immaturity
* Subject is severely overweight (BMI \> 40)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02344160
Study Brief:
Protocol Section:
NCT02344160