The Effects of Large Head MoM Hip Prosthesis on Soft Tissue: Study With 3 Tesla NMR (MoM_&_3Tesla)

May 9, 2023 updated by: Istituto Ortopedico Rizzoli

The Effects of Large Head Metal on Metal (MOM) Hip Prosthesis on Soft Tissue: Study With 3 Tesla Nuclear Magnetic Resonance (NMR)

Symptomatic and asymptomatic patients wearing Metal on Metal hip prosthesis will be enrolled in the study and periimplant pseudotumors will be searched by means of NMR (Nuclear Magnetic Resonance).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients wearing MoM (Metal on Metal) hip prosthesis, head >= 36 mm

Description

Inclusion Criteria:

  • Patients wearing MoM hip prosthesis
  • Head >= 36 mm

Exclusion Criteria:

  • Presence of ferromagnetic implants and/or presence of clinical situations that are not compatible with NMR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic
Patients with pain and or other sign of prothesis failure
Procedure: NMR
NMR
Asymptomatic
Patients with regular clinical and radiographic evolution of the implant. No pain
Procedure: NMR
NMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of pseudotumor
Time Frame: at first NMR, between 3 and 6 yrs from surgery
First NMR will be offered to patients in a period comprised between 3 and 6 yrs from surgery
at first NMR, between 3 and 6 yrs from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MoM and 3 Tesla

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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