Hip Athroplasty Using M2a Magnum Clinical Trial
Official title:
The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
| Verified date | January 2018 |
| Source | Zimmer Biomet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | December 31, 2017 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: • Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013. Exclusion Criteria: - If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place). - If the patient is contraindicated for any of the diagnostic tests. - If the patient fails to consent to participating in the study. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Basingstoke and North Hampshire Hospital | Basingstoke |
| Lead Sponsor | Collaborator |
|---|---|
| Zimmer Biomet |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MRI Scoring change in soft tissue mass size | MRI Score - monitor number and size of soft tissue lesions | 36 months after primary device implantation | |
| Secondary | Radiographic assessment | Assess acetabular cup inclincation and version | 36 months after primary device implantation | |
| Secondary | Oxford Hip Score | Oxford Hip Score, score range 0 (worst) to 48 (best) | 36 months after primary device implantation | |
| Secondary | 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 | |
| Secondary | EQ-5D | EQ-5D Index score; Patient Reported Outcome | 36 months after primary device implantation | |
| Secondary | Metal Ion Levels | Chromium and Cobalt metal ion levels in blood | 36 months after primary device implantation |