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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01884532
Eligibility Criteria:
Inclusion Criteria:
1. Able to (or capable of) provide written, voluntary consent to participate in the clinical investigation,
2. Is willing and able to return for all protocol defined clinic visits,
3. Subject has (or had, if previously revised) a combination of the following implants in the study hip:
1. ASR-XL cup or ASR 300 cup
2. XL femoral head
3. ASR-XL tapered sleeve adapter
4. One of the following stems
i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem AMT
4. Subject has high quality films available for review that were taken within 12 months of primary surgery of the following views:
1. Standing AP-Pelvis
2. Standing AP-Proximal Femur (if this view is not available but the AP-Pelvis shows the entire implant and greater trochanter, that is also acceptable)
3. Lauenstien Lateral Proximal Femur (Lateral-femur).
Exclusion Criteria:
1. The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, the medical office staff and/or representatives from the FDA
2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components
3. The femoral component is the ASR hemi or some other hemi device.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01884532
Study Brief:
Protocol Section:
NCT01884532