Hip Disease, Hip Osteoarthritis, Joint Pain, Osteoarthritis, Hip
Conditions
Keywords
Metal-on-Metal, MOM, Total Hip Arthroplasty, THA
Brief summary
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.
Interventions
DEVICEWright Medical Technology Metal-on-Metal Total Hip System
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.
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in Group 1, subjects must meet all of the following criteria: 1. Has been implanted with appropriate components of the WMT MOM THA System 2. Has previously undergone primary THA for any of the following: 1. non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis; 3. correction of functional deformity. 3. Is willing and able to complete required study visit(s) and assessments 4. Plans to be available for the required study visit 5. Is capable of providing sufficient blood for sampling according to blood draw procedures 6. 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: 1. Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants 2. Is not an employee of the Investigator 3. Is willing and able to provide Informed Consent document 4. Is willing and able to attend the requested study visit(s) and assessments 5. Is capable of providing sufficient blood for sampling according to blood draw procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Local Tissue Reactions (ALTR) | ≤ 8 years and > 8 years, since implantation | To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine chromium and cobalt whole blood and serum ion levels across time intervals | ≤ 8 years and > 8 years, since implantation | 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. |
| Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals | ≤ 8 years and > 8 years, since implantation | 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. |
| Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects). | ≤ 8 years and > 8 years, since implantation | Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR |
| Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects). | ≤ 8 years and > 8 years, since implantation | Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR |
Countries
United States
Outcome results
None listed