ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study

DePuy Synthes

Status: Completed

Conditions: Total Hip Arthroplasty; Adverse Local Tissue Reaction

Treatments: Device: ASR-XL Metal-on-Metal

Study type: Observational

Funder types: Industry

Identifiers

NCT01884532

11012 (Registry Identifier)

Details and patient eligibility

About

The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.

Enrollment: 146 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

146 participants in 5 patient groups

2 year post-op

Description:

Patients that underwent an ASR-XL Metal-on-Metal (MoM) total hip replacement (THR)and at the time of enrollment, based on their date of surgery, were 2 years post-operative. Alternatively, these are patients who have had their ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: ASR-XL Metal-on-Metal

3 year post-op

Description:

Patients that underwent an ASR-XL Metal-on-Metal (MoM) total hip replacement (THR)and at the time of enrollment, based on their date of surgery, were 3 years post-operative. Alternatively, these are patients who have had their ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: ASR-XL Metal-on-Metal

4 year post-op

Description:

Patients that underwent an ASR-XL Metal-on-Metal (MoM) total hip replacement (THR)and at the time of enrollment, based on their date of surgery, were 4 years post-operative. Alternatively, these are patients who have had their ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: ASR-XL Metal-on-Metal

5 year post-op

Description:

Patients that underwent an ASR-XL Metal-on-Metal (MoM) total hip replacement (THR)and at the time of enrollment, based on their date of surgery, were 5 years post-operative. Alternatively, these are patients who have had their ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: ASR-XL Metal-on-Metal

6 year post-op

Description:

Patients that underwent an ASR-XL Metal-on-Metal (MoM) total hip replacement (THR)and at the time of enrollment, based on their date of surgery, were 6 years post-operative. Alternatively, these are patients who have had their ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: ASR-XL Metal-on-Metal