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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT04541693
Eligibility Criteria:
Inclusion Criteria:
* Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
* Ability to use study device (not requiring specialized implants)
* Patients between the ages of 18+ older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent
Exclusion Criteria:
* Acute infection requiring washout, debridement, and liner exchange
* Unresolved infection
* Undergoing stage 1 of a 2-stage revision for infection
* Known metal allergy to device components
* Active participation in another clinical study (within the past 30 days)
* Known risk for loss to follow-up (significant geographical distance from treatment centre)
* BMI\>40 (severe obesity)
* Unable to provide informed consent (cognitive impairment)
* Patients requiring a bearing couple different than metal on polyethylene
* Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length)
* Patients with severe defects, dysplasia, or tumor
* Inflammatory joint disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04541693
Study Brief:
Protocol Section:
NCT04541693