Clinical trial NCT01884532: ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
Official title: Cross-Sectional, Multi-Center Evaluation of 6 Year Metal Ion Trends for ASR-XL Total Hip Replacement System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Local Tissue Reaction
Total Hip Arthroplasty
Keywords: Adverse Local Tissue Reaction
Metal Ions
Serum
Whole Blood
Metal-on-Metal
Total Hip Arthroplasty
ASR-XL Metal-on-Metal
Revised ASR-XL Metal-on-Metal
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have undergone a total hip arthroplasty with the ASR-XL Metal-on-Metal device that are currently 2 to 6 years post-operative.

Brief summary: 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.


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.

Primary outcomes:
measure: Change in Chromium serum ion level across time intervals
timeFrame: Pre-operatively through 6 years
measure: Change in Chromium whole blood ion level across time intervals
timeFrame: Pre-operatively through 6 years
measure: Change in Cobalt serum ion level across time intervals
timeFrame: Pre-operatively through 6 years
measure: Change in Cobalt whole blood ion level across time intervals
timeFrame: Pre-operatively through 6 years
Secondary outcomes:
measure: Poolability of data across stem types
timeFrame: Pre-operatively through 6 years post-operatively
measure: Incidence of adverse local tissue reaction (ALTR)
timeFrame: Pre-operatively through 6 years post-operatively
measure: Implant survivorship
timeFrame: Through 6 years post-operatively
measure: To identify the incidence of ALTR among unrevised subjects
timeFrame: Through 6 years post-operatively
measure: Ion levels among revised subjects
timeFrame: Pre-operatively through 6 years post-operatively
measure: Harris Hip and HOOS analysis for pain, function and total score
timeFrame: Through 6 years post-operatively
measure: To determine the association of adverse events with elevated ion levels
timeFrame: Through 6 years post-operatively
measure: Trending
timeFrame: Through 6 years post-operatively
measure: Patient history and demographics and association with outcomes
timeFrame: Throughout 6 years post-operatively
measure: Modes and causes of implant failure
timeFrame: Through 6 years post-operatively
measure: Metal ion levels and association with reason for revision
timeFrame: Through 6 years post-operatively
measure: Comparison of metal ion levels across subjects with vs. without ALTR
timeFrame: Through 6 years post-operatively
measure: Ion level vs. baseline for ALTR subjects
timeFrame: Through 6 years post-operatively
measure: Ion level change from first measurement for ALTR subjects
timeFrame: Through 6 years post-operatively
Other outcomes:
Locations:
city: Fort Collins
country: United States
state: Colorado
city: Glenview
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Las Vegas
country: United States
state: Nevada
city: Durham
country: United States
state: North Carolina
city: Cincinnatti
country: United States
state: Ohio
city: Austin
country: United States
state: Texas
Study officials:
affiliation: DePuy Synthes Joint Reconstruction
name: Mary F Panozzo, BS
role: STUDY_DIRECTOR
References: