Metal-on-metal Hip Replacement MRI Study

The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03409640

Enrollment

100

Registered

2018-01-24

Start date

2014-01-17

Completion date

2017-12-31

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Athroplasty Using M2a Magnum

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
MRI Scoring change in soft tissue mass size	36 months after primary device implantation	MRI Score - monitor number and size of soft tissue lesions

Secondary

Measure	Time frame	Description
Oxford Hip Score	36 months after primary device implantation	Oxford Hip Score, score range 0 (worst) to 48 (best)
Radiographic assessment	36 months after primary device implantation	Assess acetabular cup inclincation and version
UCLA Activity Score	36 months after primary device implantation	UCLA activity scale, range: 1 defined as no physical activity, dependent on others to 10 defined as regular participation in impact sports.
EQ-5D	36 months after primary device implantation	EQ-5D Index score; Patient Reported Outcome
Metal Ion Levels	36 months after primary device implantation	Chromium and Cobalt metal ion levels in blood

Countries

United Kingdom

Outcome results