Metal-on-metal Hip Replacement MRI Study

Completed

• Conditions: Hip Athroplasty Using M2a Magnum

• Registration Number: NCT03409640
• Lead Sponsor: Zimmer Biomet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-17
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-01
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Study First Posted: 2018-01-24
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Radiographic assessment	36 months after primary device implantation	Assess acetabular cup inclincation and version
Oxford Hip Score	36 months after primary device implantation	Oxford Hip Score, score range 0 (worst) to 48 (best)
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

Trial Locations

Locations (1)

Basingstoke and North Hampshire Hospital; 🇬🇧 Basingstoke, United Kingdom