The Effects of Large Head MoM Hip Prosthesis on Soft Tissue: Study With 3 Tesla NMR

NCT ID: NCT02793726

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Prostheses and Implants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Symptomatic

Patients with pain and or other sign of prothesis failure

NMR

Intervention Type PROCEDURE

NMR

Asymptomatic

Patients with regular clinical and radiographic evolution of the implant. No pain

NMR

Intervention Type PROCEDURE

NMR

Interventions

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NMR

NMR

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MoM and 3 Tesla

Identifier Type: -

Identifier Source: org_study_id

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