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This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and > 8 years, since implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously Implanted (Group 1) | Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System |
| |
| Control (Group 2) | Control, non-implanted subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wright Medical Technology Metal-on-Metal Total Hip System | Device | Subjects in Group 1 previously implanted prior to the study start date will be identified from Investigator records. Collected data will be evaluated in aggregate and cross-sectioned by year of implantation. Subjects will be cross-sectioned by the time that has elapsed between implantation and the initial visit (e.g. 5 years, 6 years) using contiguous visit windows (number of years + 6 months). Subject data will be grouped in order to create cross-sectional epochs of ≤ 8 years and > 8 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Local Tissue Reactions (ALTR) | To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1) | ≤ 8 years and > 8 years, since implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Determine chromium and cobalt whole blood and serum ion levels across time intervals | Cobalt and chromium metal ion levels will be measured in whole blood and serum from subjects implanted with the WMT MoM THA System (Group 1) at each defined cross-section interval. | ≤ 8 years and > 8 years, since implantation |
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Inclusion Criteria:
To be included in Group 1, subjects must meet all of the following criteria:
Has been implanted with appropriate components of the WMT MOM THA System
Has previously undergone primary THA for any of the following:
Is willing and able to complete required study visit(s) and assessments
Plans to be available for the required study visit
Is capable of providing sufficient blood for sampling according to blood draw procedures
Is willing to sign the approved Informed Consent document
Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4) the subject agrees to a second Informed Consent document and data collection specific to the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted in this study.
To be included in Group 2, subjects must meet all of the following criteria:
Exclusion Criteria:
Subjects will be excluded from either study group if they meet any of the following criteria:
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Group 1: Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System
Group 2: Control, non-implanted subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriWest Research Associates | El Cajon | California | 92020 | United States | ||
| BioSolutions Research Center |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Whole blood and serum samples will be retained
|
| Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals |
Analyze difference in chromium and cobalt whole blood and serum ion levels in subjects implanted with the WMT MoM THA System (Group 1) versus control subjects (Group 2) cross-sectionally. |
| ≤ 8 years and > 8 years, since implantation |
| Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects). | Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR | ≤ 8 years and > 8 years, since implantation |
| Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects). | Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR | ≤ 8 years and > 8 years, since implantation |
| La Mesa |
| California |
| 91942 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Spokane Joint Replacement Center, Inc. | Spokane | Washington | 99208 | United States |
| D012216 |
| Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |