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| ID | Type | Description | Link |
|---|---|---|---|
| PS110005-28 | Other Identifier | FDA |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-THA | Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure. | ||
| Metal-on-Poly | Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006. | ||
| M2a Magnum hip | Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011. | ||
| M2a38 hip | Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006. | ||
| M2a Ringloc hip | Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004. | ||
| M2a Taperloc hip | Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003. |
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| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass | Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass | Patients 1 year post-implantation up to 10 years post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb | 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. | 1 Year through 10 Years Postop |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have received the indicated implants at one of four participating centers and who meet the sampling plan requirements.
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| Name | Affiliation | Role |
|---|---|---|
| Russell Schenck, Ph.D. | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ortho Michigan | Flint | Michigan | 48507 | United States | ||
| Joint Implant Surgeons |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Metal-on-Poly | Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006. |
| FG001 | M2a Magnum Hip | Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011. |
| FG002 | M2a38 Hip | Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006. |
| FG003 | M2a Ringloc Hip | Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004. |
| FG004 | M2a Taperloc Hip | Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003. |
| FG005 | Pre-THA | Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Although 137 subjects with the M2a Magnum hip were followed, only 132 had demographic information obtained (2 subjects missing data from 3 Year Cohort, 2 subjects missing data from 4 Year Cohort, and 1 subject missing data from 6 Year Cohort). Furthermore, 56 subjects with the M2a38 hip were followed, however only 54 had demographic information available (2 subjects missing data from 7 Year Cohort).
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-THA | Patients who are prospectively planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure. |
| BG001 | Metal-on-Poly |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass | Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass | Patients in each symptomatic group evaluated with an adverse local tissue reaction (ALTR), which is determined based on the presence of an age-related macular degeneration (ARMD) of any level of severity, detected on the MRI. Patients in each asymptomatic group evaluated without an ALTP detected on the MRI. | Posted | Count of Participants | Participants | Patients 1 year post-implantation up to 10 years post implantation |
|
Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metal-on-Poly | Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ambulation Difficulties | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Operations | Zimmer Biomet | 1-800-613-6131 | clinicaldirector@zimmerbiomet.com |
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| New Albany |
| Ohio |
| 43054 |
| United States |
| Midlands Orthopaedics | Columbia | South Carolina | 29201 | United States |
| Texas Center for Joint Replacement | Plano | Texas | 75093 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
Retrospectively enrolled patients who received a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
| BG002 | M2a Magnum Hip | Retrospectively enrolled patients who received a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011. |
| BG003 | M2a38 Hip | Retrospectively enrolled patients who received a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006. |
| BG004 | M2a Ringloc Hip | Retrospectively enrolled patients who received a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004. |
| BG005 | M2a Taperloc Hip | Retrospectively enrolled patients who received a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003. |
| BG006 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| M2a 38mm Hip- 6 Year Cohort |
Patients receiving a Biomet metal on metal M2a38mm hip, 6 Years Postop |
| OG002 | M2a 38mm Hip- 7 Year Cohort | Patients receiving a Biomet metal on metal M2a38mm hip, 7 Years Postop |
| OG003 | M2a 38mm Hip- 8 Year Cohort | Patients receiving a Biomet metal on metal M2a 38mm hip, 8 Years Postop |
| OG004 | M2a 38mm Hip- 10 Year Cohort | Patients receiving a Biomet metal on metal M2a 38mm hip, 10 Years Postop |
| OG005 | M2a Magnum Hip- 1 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 1 Year Postop |
| OG006 | M2a Magnum Hip- 2 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 2 Years Postop |
| OG007 | M2a Magnum Hip- 3 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 3 Years Postop |
| OG008 | M2a Magnum Hip- 4 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 4 Years Postop |
| OG009 | M2a Magnum Hip- 5 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 5 Years Postop |
| OG010 | M2a Magnum Hip- 6 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 6 Years Postop |
| OG011 | M2a Magnum Hip- 8 Year Cohort | Patient receiving a Biomet M2a Magnum Hip, 8 Years Postop |
| OG012 | M2a Ringloc Hip- 8 Year Cohort | Patient receiving a Biomet M2a Ringloc Hip, 8 Years Postop |
| OG013 | M2a Ringloc Hip- 9 Year Cohort | Patient receiving a Biomet M2a Ringloc Hip, 9 Years Postop |
| OG014 | M2a Ringloc Hip- 10 Year Cohort | Patient receiving a Biomet M2a Ringloc Hip, 10 Years Postop |
| OG015 | M2a Taper Hip- 9 Year Cohort | Patient receiving a Biomet M2a Taper Hip, 9 Years Postop |
| OG016 | M2a Taper Hip- 10 Year Cohort | Patient receiving a Biomet M2a Taper Hip, 10 Years Postop |
| OG017 | Metal on Poly Hip- 6 Year Cohort | Patient receiving a Biomet Metal on Poly Hip, 6 Years Postop |
| OG018 | Metal on Poly Hip- 7 Year Cohort | Patient receiving a Biomet Metal on Poly Hip, 7 Years Postop |
| OG019 | Metal on Poly Hip- 8 Year Cohort | Patient receiving a Biomet Metal on Poly Hip, 8 Years Postop |
| OG020 | Metal on Poly Hip- 9 Year Cohort | Patient receiving a Biomet Metal on Poly Hip, 9 Years Postop |
|
|
| Secondary | Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb | 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. | The Analysis group does not include the 104 subjects from the Pre-operative group and the 9 subjects that were Screen Failures | Posted | Count of Participants | Participants | 1 Year through 10 Years Postop |
|
|
|
| 0 |
| 78 |
| 78 |
| 78 |
| 0 |
| 0 |
| EG001 | M2a Magnum Hip (1-3 Years) | Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2009. | 0 | 58 | 58 | 58 | 0 | 0 |
| EG002 | M2a Magnum Hip (4-8 Years) | Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2009 and January 1, 2011. | 0 | 79 | 79 | 79 | 0 | 0 |
| EG003 | M2a38 Hip | Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006. | 0 | 56 | 56 | 56 | 0 | 0 |
| EG004 | M2a Ringloc Hip | Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004. | 0 | 9 | 9 | 9 | 0 | 0 |
| EG005 | M2a Taperloc Hip | Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003. | 0 | 13 | 13 | 13 | 0 | 0 |
| Artery Damage/Vascular Disorder | Vascular disorders | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Decreased Range Of Motion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Discoloration/Rash In Wound Area | Infections and infestations | Non-systematic Assessment |
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| Dislocation/Subluxation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Early/Late Infection | Infections and infestations | Non-systematic Assessment |
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| Effusion >3 Mos | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Femoral Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Grinding/Negative Sensation In Hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Heterotopic Ossification | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Implant Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Implant Loosening/ Radiolucency | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Joint Deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Knee/Ankle Problems Ipsilateral Side | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Leg Length Discrepancy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Limp> 3 Mos Post-Op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Loss Of Function Compared To Pre-Op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Mild/Moderate Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nerve Damage/Nerve Palsy | Nervous system disorders | Non-systematic Assessment |
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| Numbness | Nervous system disorders | Non-systematic Assessment |
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| Other - Right Foot Problem | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pelvic Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | Non-systematic Assessment |
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| Severe Pain > 3 Mos Post-Op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Snapping/Popping/Other Audible Noise | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Tenderness At Implant Site > 3 Mos Post-Op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Trochanteric Avulsion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Unexplained Mass Or Swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Wound Problems> 3mos Post-Op | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Allergy/Immunological | Immune system disorders | Systematic Assessment |
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| Auditory | Ear and labyrinth disorders | Systematic Assessment |
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| Cardiopulmonary | Cardiac disorders | Systematic Assessment |
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| Dermotology (Not At Implant Site) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Endocrine | Endocrine disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Hematological (Not At Implant Site) | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphatic | Blood and lymphatic system disorders | Systematic Assessment |
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| Mild/Moderate Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Neurological (Not At Implant Site) | Nervous system disorders | Systematic Assessment |
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| Numbness | Nervous system disorders | Systematic Assessment |
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| Ocular/Visual | Eye disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Psychiatric | Psychiatric disorders | Systematic Assessment |
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| Urogenital | Renal and urinary disorders | Systematic Assessment |
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| Male |
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