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Metal-on-metal Hip Replacement MRI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409640
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hip Athroplasty Using M2a Magnum

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
Actual Study Start Date : January 17, 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Radiographic assessment [ Time Frame: 36 months after primary device implantation ]
    Assess acetabular cup inclincation and version

  2. Oxford Hip Score [ Time Frame: 36 months after primary device implantation ]
    Oxford Hip Score, score range 0 (worst) to 48 (best)

  3. 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."

  4. EQ-5D [ Time Frame: 36 months after primary device implantation ]
    EQ-5D Index score; Patient Reported Outcome

  5. Metal Ion Levels [ Time Frame: 36 months after primary device implantation ]
    Chromium and Cobalt metal ion levels in blood



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving either the M2a Magnum or M2a 38mm Metal on Metal primary hip replacement devices from a single study centre.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409640


Locations
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United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA
Sponsors and Collaborators
Zimmer Biomet

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03409640     History of Changes
Other Study ID Numbers: ORTHO.CR.GH34
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No