Completed

NCT Number: NCT03409640

Metal-on-metal Hip Replacement MRI Study

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.

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Key information

Conditions

Hip Athroplasty Using M2a Magnum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Basingstoke and North Hampshire Hospital

Basingstoke, RG24 9NA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

MRI Scoring change in soft tissue mass size

Time frame: 36 months after primary device implantation

MRI Score - monitor number and size of soft tissue lesions

Secondary outcomes

Radiographic assessment

Time frame: 36 months after primary device implantation

Assess acetabular cup inclincation and version
Oxford Hip Score

Time frame: 36 months after primary device implantation

Oxford Hip Score, score range 0 (worst) to 48 (best)
UCLA Activity Score

Time frame: 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

Time frame: 36 months after primary device implantation

EQ-5D Index score; Patient Reported Outcome
Metal Ion Levels

Time frame: 36 months after primary device implantation

Chromium and Cobalt metal ion levels in blood

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jan 24, 2018
Registry last updated: Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.