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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02793726
Other study ID # MoM and 3 Tesla
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date May 2017

Study information

Verified date June 2016
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
NMR
NMR

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of pseudotumor 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
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