Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study

DePuy Synthes

Status: Completed

Conditions: Total Hip Arthroplasty; Pinnacle Metal-on-Metal; Metal Ions; Adverse Local Tissue Reaction; Revised Pinnacle Metal-on-Metal

Treatments: Device: Pinnacle Metal-on Metal

Study type: Observational

Funder types: Industry

Identifiers

NCT01828801

10017

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 Pinnacle Acetabular MoM system.

Enrollment: 276 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 a combination of the following implants in the study hip (unless in pre-op cohort):

   1. Pinnacle acetabular shell with or without Gription TM porous coating
   2. M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
   3. Ultamet metal insert
   4. One of the following stems

   i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem

4. Subject has high quality films available for review that were taken within 12 months of the 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. Lauenstein 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 FDA
2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
3. The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
4. FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
5. FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip

Trial design

276 participants in 9 patient groups

Pre-Op

Description:

Pre-operative patients who will undergo a total hip replacement.

1 year post-op

Description:

Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 1 year post-operative . Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

2 year post-op

Description:

Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

3 year post-op

Description:

Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

4 year post-op

Description:

Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

5 year post-op

Description:

Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

6 year post-op

Description:

Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

7 year post-op

Description:

Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 7 years post-operative . Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal

8 year post-op

Description:

Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 8 years post-operative . Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.

Treatment:

Device: Pinnacle Metal-on Metal