Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| MRI Scoring change in soft tissue mass size | MRI Score - monitor number and size of soft tissue lesions | 36 months after primary device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic assessment | Assess acetabular cup inclincation and version | 36 months after primary device implantation |
| Oxford Hip Score | Oxford Hip Score, score range 0 (worst) to 48 (best) |
Not provided
Inclusion Criteria:
• Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients receiving either the M2a Magnum or M2a 38mm Metal on Metal primary hip replacement devices from a single study centre.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basingstoke and North Hampshire Hospital | Basingstoke | RG24 9NA | United Kingdom |
Not provided
Not provided
Not provided
Not provided
| 36 months after primary device implantation |
| UCLA Activity Score | UCLA activity scale, range: 1 defined as "no physical activity, dependent on others" to 10 defined as "regular participation in impact sports." | 36 months after primary device implantation |
| EQ-5D | EQ-5D Index score; Patient Reported Outcome | 36 months after primary device implantation |
| Metal Ion Levels | Chromium and Cobalt metal ion levels in blood | 36 months after primary device implantation |