Elevated Blood Ion Levels, Tissue Reaction
Conditions
Brief summary
Retrospective study to comply with FDA's post-market surveillance order. The purpose of the study is to contact patients who have received a Biomet metal-on-metal product as their primary total hip arthroplasty device. Patients who have not been revised prior to contact will be asked to submit to a blood draw, clinical exam and MRI.
Detailed description
This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of five Biomet implant types; a MOP primary THA, an M2a 38, M2a Taper, M2a Ringloc and M2a Magnum MOM primary THA device in 308-436 total patients at four centers. The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to evaluate whether the occurrence of soft tissue changes is related to any of several potential covariates including patient and implant characteristics and time in situ.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* patient meets the sampling plan requirements
Exclusion criteria
* patient is contraindicated for MRI * patient fails to consent for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass | Patients 1 year post-implantation up to 10 years post implantation | Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb | 1 Year through 10 Years Postop | The outcome measure will show the number of subjects in all post-operative cohorts determined to have metal ion concentrations in whole blood and serum \>7ppb in each study arm. |
Countries
United States
Contacts
STUDY_DIRECTORRussell Schenck, Ph.D.
Zimmer Biomet
Participant flow
Pre-assignment details
Pre-THA cases who are consented to provide blood samples that serve as the baseline for the metal ion testing. Post-Operative cases cases with an existing MoP or MoM hip replacement in the specified timeframe who have been consented to participate in the study. Post-Operative Description of Analysis Cohort for each Post-Operative Group: M2a \> 144; Meta on Poly \> 100; M2a 38 \> 24-72; M2a Taper \> 16-48; M2a Ringloc \> 24-72; Total \> 308-436
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 10 Year Cohort | 52.17 years |
| Age, Customized 1 Year Cohort | 55.5 years |
| Age, Customized 2 Year Cohort | 57.3 years |
| Age, Customized 3 Year Cohort | 56.8 years |
| Age, Customized 4 Year Cohort | 57.8 years |
| Age, Customized 5 Year Cohort | 59.7 years |
| Age, Customized 6 Year Cohort | 67.8 years |
| Age, Customized 7 Year Cohort | 58.6 years |
| Age, Customized 8 Year Cohort | 58.18 years |
| Age, Customized 9 Year Cohort | 64.0 years |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 58 | 0 / 79 | 0 / 56 | 0 / 9 | 0 / 13 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 78 / 78 | 58 / 58 | 79 / 79 | 56 / 56 | 9 / 9 | 13 / 13 |
Outcome results
None listed